Career
7
Contact us
Career
7
Contact us

Our Finished Products Engineers

Pharma4ever delivers expert finished products engineering consultancy for pharmaceutical, biotech and medical device companies. We specialize in the field of pharma engineering, and focus solely on reaching goals and added value. 

Given our extensive in-house experience, we truly understand the challenges faced by our customers, be it filling, assembly and packing of pharmaceutical products. That’s why we take a streamlined, focused approach and combine it with in-depth knowledge in order to meet project goals and deliver on time and on budget.

Main Services

  • Designing, commissioning and qualification of filling, assembly and packaging lines
  • Project management
  • Production optimization & root cause analysis 
  • Vision inspection
  • Automation
  • Heat studies of buildings and equipment

+ knowhow on tablets, blisters, PFS and pen systems in relation to the above topics

Talk to a pharma expert

All our employees have many years of hands-on experience in the industry. This is the main reason why Pharma4ever delivers such an impactful understanding of the technical, human and compliance related issues within the field of pharma engineering.

Select the case category of your interest

Automation (PLC/SCADA)
Commissioning and qualification of production equipment
Project management
Heat studies of buildings and equipment
Production optimization & root cause analyze

Challenges we often experience

Complexity in project management

Difficulty navigating complex projects, which can lead to delays and budget overruns.

Lack of internal expertise

It's challenging to locate the required specialized skills within the organization, hindering both the advancement of the project portfolio and its potential for innovation.

Risk of errors and rework

Inexperience can increase the risk of errors, resulting in time-consuming rework and additional costs.

Insufficient risk management

Absence of mechanisms to properly recognize and handle risks, potentially resulting in unexpected issues as the project unfolds.

' '

Left behind after big projects

The feeling of being left behind by your engineering partner after the completion of a large project, especially when the hypercare phase is overlooked, can create uncertainty and frustration in the team.

Undervaluation of brownfield initiatives

There is a widespread belief that brownfield redevelopment projects are frequently given lower priority, leading to the engagement of less seasoned consultants for these projects.

Challenges in Operational Excellence

Varying peak loads in production present difficulties related to deviations, initiatives to enhance standard operating procedures (SOP), and overall equipment effectiveness (OEE), especially in the absence of skilled and flexible support.

Project Manager (PM)

Project Manager Assistant

Work Package Owner (WPO)

Equipment Responsible (ER)

Operational Responsible (OR)

Validation Lead

Automation Lead

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Brings proven methods and structure from 200+ complex pharma projects
  • Breaks down complexity into manageable phases with clear priorities
  • Ensures team alignment across disciplines and stakeholders
  • Prevents delays by anticipating and resolving dependencies early

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Adds structure and clarity to projects with many moving parts
  • Supports the PM with planning, coordination, and documentation
  • Keeps timelines, action logs, and stakeholders aligned
  • Acts as the glue that keeps the project engine running smoothly

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Owns specific technical or functional areas with clear accountability
  • Translates overall project goals into tangible workstreams
  • Coordinates closely with other disciplines to resolve interdependencies
  • Brings focus and progress to complex deliverables

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Manages technical scope within complex equipment-related workstreams
  • Aligns specifications and timelines with stakeholders and project goals
  • Coordinates FAT, installation, and SAT without disrupting other workstreams
  • Prevents delays by managing dependencies and readiness of systems

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Represents the voice of operations in project decisions
  • Ensures solutions are aligned with daily routines and operator needs
  • Translates complex project terms into practical reality
  • Identifies and addresses operational blind spots early

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Integrates validation plans seamlessly into complex project schedules
  • Prevents validation from becoming a bottleneck late in the project
  • Coordinates with QA, engineering, and production for alignment
  • Ensures traceability and structure across all qualification activities

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Designs automation systems tailored to complex project scopes
  • Aligns hardware, software, and compliance needs early
  • Bridges between IT, OT, QA, and engineering
  • Delivers robust and integrated automation solutions

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Acts as a strong decision-maker when internal experience is limited
  • Guides teams safely through unfamiliar project environments
  • Transfers knowledge to internal staff along the way
  • Ensures momentum by avoiding trial-and-error approaches

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Provides professional project support where internal bandwidth is limited
  • Helps inexperienced teams stay on track with proven methods
  • Bridges gaps in planning, follow-up, and documentation
  • Enables the PM and team to focus on decision-making

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Fills in gaps where internal know-how is missing or stretched thin
  • Takes ownership of specialized work packages without needing micromanagement
  • Brings deep experience with pharma execution models
  • Guides the team safely through unfamiliar technical territory

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Brings deep knowledge of equipment lifecycle and supplier management
  • Supports decision-making on technical specs and quality standards
  • Takes lead on installation and commissioning activities
  • Provides assurance when in-house experience is limited

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Acts as a process owner where experience is limited internally
  • Brings hands-on knowledge from other pharma operations
  • Provides clarity on SOPs, batch flows, and critical parameters
  • Ensures smooth operational acceptance after implementation

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Brings deep GMP understanding when in-house validation is limited
  • Designs lean and compliant validation strategies
  • Prepares documentation that meets authority expectations
  • Coaches team members in validation principles and practices

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Supplements limited internal automation capacity
  • Guides design, configuration, and documentation with expertise
  • Prevents costly trial-and-error development
  • Ensures systems meet both user and GMP expectations

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Sets up processes that prevent costly mistakes and miscommunication
  • Ensures quality gates and documentation are followed from day one
  • Creates transparency and accountability across the team
  • Delivers right-first-time execution in high-compliance settings

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Tracks tasks, deadlines, and dependencies to avoid mistakes
  • Maintains clear documentation and audit trails
  • Ensures version control and status clarity across deliverables
  • Acts as early warning for missing inputs or misaligned workstreams

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Ensures clear scope, interfaces, and acceptance criteria for assigned packages
  • Aligns expectations early and follows through with documentation
  • Reduces rework by managing quality from the start
  • Provides hands-on control of execution and follow-up

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Ensures right-first-time equipment delivery through clear documentation
  • Prevents installation issues by coordinating trades and vendors
  • Validates alignment with URS and process design early
  • Reduces costly corrections through proactive quality control

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Prevents process misalignment by reviewing designs from the floor-level
  • Reduces handover errors through early engagement
  • Validates whether proposed solutions are usable and effective
  • Avoids rework through operational testing and involvement

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Prevents last-minute surprises by defining quality early
  • Identifies documentation gaps before inspections or audits
  • Aligns protocols with design specifications and user needs
  • Reduces rework by getting validation right the first time

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Applies structured testing and validation protocols
  • Anticipates integration issues between platforms
  • Ensures accurate data capture and alarm handling
  • Reduces programming and logic errors through standardization

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Implements proactive risk planning across workstreams
  • Brings experience in identifying hidden risks and critical paths
  • Ensures mitigation actions are followed up continuously
  • Helps maintain compliance and stakeholder confidence

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Supports the setup and follow-up of risk registers and mitigation plans
  • Ensures meeting notes and risk actions don’t fall through the cracks
  • Helps keep stakeholders informed and aligned on critical risks
  • Strengthens control through structure and traceability

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Anticipates risks within their area and raises flags proactively
  • Tracks mitigations and updates risk logs related to their scope
  • Aligns with QA and compliance functions to reduce blind spots
  • Helps keep the broader risk picture complete and current

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Identifies equipment-related risks before procurement and delivery
  • Implements mitigation plans related to technical delays and integration
  • Aligns with QA and validation to address compliance-critical risks
  • Supports cross-functional risk reviews with actionable insights

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Highlights operational risks others may overlook
  • Validates impact of technical risks on production
  • Ensures that mitigation plans cover the end-user perspective
  • Helps prevent downtime and bottlenecks post go-live

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Conducts risk assessments to determine validation scope
  • Focuses effort where it matters most for product safety and compliance
  • Prevents over-validation or blind spots
  • Ensures timely identification and mitigation of quality risks

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Assesses automation-specific risks early in design
  • Mitigates risks around system downtime and data loss
  • Ensures cyber and data integrity protections are built-in
  • Aligns risk handling with GAMP and compliance expectations

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Ensures structured handover and operational readiness before close-out
  • Involves end-users and stakeholders early in the transition process
  • Builds ownership among the line organization
  • Prevents “project drop” by staying until solutions work in practice

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Helps prepare user documentation, SOPs, and training materials
  • Ensures knowledge transfer to operations isn’t forgotten
  • Tracks outstanding actions during hypercare phase
  • Creates transparency in handover and closure activities

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Ensures that deliverables are handed over fully and correctly
  • Supports the transition from project mode to operational mode
  • Stays available for troubleshooting during go-live and hypercare
  • Provides technical background and ownership to the receiving teams

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Prepares comprehensive handover of equipment documentation and status
  • Coordinates training and maintenance handover for operations
  • Ensures proper spare parts and service agreements are in place
  • Minimizes operational disruptions after project closeout

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Takes ownership of new solutions in the line organization
  • Ensures readiness for production startup and shift integration
  • Supports hypercare and captures improvement feedback
  • Minimizes transition friction between project and operations

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Closes out validation activities fully and properly
  • Delivers complete validation documentation ready for inspection
  • Supports QA handover and ongoing qualification
  • Ensures sustainable compliance beyond the project phase

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Transfers automation knowledge to internal support teams
  • Documents code, logic, and test reports thoroughly
  • Ensures backup, versioning, and recovery plans are in place
  • Supports stabilization and debugging after go-live

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Knows how to scope and execute upgrades in live environments
  • Anticipates integration issues with legacy systems and infrastructure
  • Avoids downtime through tight coordination and phasing
  • Helps build business case and stakeholder support for brownfield efforts

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Provides the same professional support as in major projects
  • Ensures that smaller upgrades don’t suffer from lack of structure
  • Brings visibility to brownfield progress and blockers
  • Helps secure follow-through on business-critical upgrades

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Understands the challenges of modifying existing equipment or systems
  • Plans around constraints like space, access, and ongoing production
  • Delivers results even in messy, non-standard environments
  • Ensures brownfield packages are treated with the same rigor as greenfield

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Experienced in working within existing systems and physical constraints
  • Identifies and mitigates risks tied to integration and access
  • Manages installations during live production without downtime
  • Brings the same structure as in greenfield projects to brownfield scopes

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Champions small but important changes in legacy systems
  • Ensures operational efficiency and safety in brownfield upgrades
  • Communicates value of local improvements to stakeholders
  • Secures involvement and follow-up in overlooked projects

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Designs scalable validation strategies for system upgrades
  • Ensures compliance even in complex existing setups
  • Bridges new and old processes in documentation and testing

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Understands legacy systems and how to upgrade without disruption
  • Manages integrations across generations of automation platforms
  • Enhances functionality in existing plants without full replacement
  • Demonstrates impact of automation improvements with real metrics

Role and Responsibility:

  • Overall responsibility for project progress, budget, and deliverables.
  • Ensures that the project meets stakeholder requirements and stays on schedule.
  • Coordinates resources, risk management, and communication between teams.
  • Escalates challenges and makes strategic decisions.

Advantages:

  • Turns strategic OE goals into executable project plans
  • Aligns improvement initiatives with day-to-day realities
  • Uses data to drive continuous improvement culture
  • Delivers real change, not just presentations and workshops

Role and Responsibility:

  • Supports the PM with administrative and coordination tasks.
  • Prepares reports, meeting agendas, and documentation.
  • Follows up on action points and project plans.
  • Assists with communication between project stakeholders.

Advantages:

  • Tracks OE initiatives and KPIs for progress reporting
  • Supports communication across departments and teams
  • Maintains the momentum of improvement activities
  • Ensures structure and accountability in follow-up

Role and Responsibility:

  • Responsible for a specific part (work package) of the project.
  • Ensures the work package is delivered on time, within budget, and with the required quality.
  • Coordinates with underlying roles (e.g., ER, OR, Validation Lead, Automation Lead).
  • Aligns requirements with the PM and other teams.

Advantages:

  • Understands the challenges of modifying existing equipment or systems
  • Plans around constraints like space, access, and ongoing production
  • Delivers results even in messy, non-standard environments
  • Ensures brownfield packages are treated with the same rigor as greenfield

Role and Responsibility:

  • Responsible for specific technical components or equipment.
  • Ensures the equipment meets specifications according to URS, additional design documentation and regulatory requirements.
  • Collaborates with vendors and project teams on installation and qualification. (often the ER overtakes the responsibility of the validation as well)
  • Troubleshoots and provides technical support during implementation and operation.

Advantages:

  • Improves equipment uptime and maintainability through best practices
  • Supports upgrades and modifications that boost OEE and performance
  • Facilitates root cause analysis and improvement initiatives
  • Bridges between operations and technical functions

Role and Responsibility:

  • Focuses on the operational implementation and usability of the system/equipment.
  • Ensures that the solution is practical for production or operation (URS responsible)
  • Responsible for procedures and user training.
  • Works closely with ER and Validation Lead to ensure compliance.

Advantages:

  • Leads operational improvement initiatives across teams
  • Builds routines that reinforce continuous improvement
  • Engages colleagues in identifying pain points and solutions
  • Ensures lasting results from OE projects – not just short-term wins

Role and Responsibility:

  • Overall responsibility for validation activities within the project according to Science and Risk-based validation
  • Ensures that processes, systems, and equipment comply with regulatory requirements (GMP, FDA, EU Annex 15, etc.).
  • Develops validation plans, test protocols (IQ, OQ, PQ), and documentation.
  • Collaborates with OR and ER to ensure successful validation execution.

Advantages:

  • Ensures improvements don’t compromise compliance
  • Updates validation as part of change control and optimization
  • Validates changes efficiently to avoid delay
  • Supports data integrity and process robustness

Role and Responsibility:

  • Responsible for automation systems and process control within the project.
  • Develops and implements software and control strategies (SCADA, PLC, DCS).
  • Ensures system integration and compliance with regulations.
  • Works with the Validation Lead on testing and qualification of automation systems.

Advantages:

  • Enables data-driven improvement through automation solutions
  • Builds dashboards, alerts, and reports for performance tracking
  • Automates repetitive tasks and error-prone manual steps
  • Delivers digital tools that support continuous improvement

Co-founder / Managing Partner in Finished Products Engineering

Bo Hejgaard Pedersen

Shall we chat about the particularities of your project?

Insights from our finished product engineering family

Go the career site to learn more

Here’s a review from one of our close costumers –Poul Johansen Maskiner A/S– on how we helped set the validation- and test strategy for their pharmaceutical projects. 

It’s feedback such as “the collaboration with Pharma4ever in the team was excellent” or “Pharma4ever integrated into the project team seamlessly” that makes us proud of our work, and drives us to become the best possible engineering partner in the Pharmaceutical and medical device landscape.

John Bo Jakobsen, Design & Engineering - Poul Johansen Maskiner A/S
You want to talk about:(Required)
This field is for validation purposes and should be left unchanged.
DSC01525
DSC01740
DSC01777
DSC01823

Pharma4ever

  • Hørkær 24, 2730 Herlev

Info

Social media

Linkedin Youtube

Pharma4ever Engineering

Pharma4ever FP

Pharma4ever QA

© 2025 pharma4ever.com – Designet af Aveo web&marketing

Contact us

You want to talk about:(Required)
This field is for validation purposes and should be left unchanged.
Do you want to know more about Finished Products Engineering?
Contact us
Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?
Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?
Do you want to know more about Finished Products Engineering?
Do you want to know more Process Engineers?
Do you want to know more Medical Device & QA?