General optimization and project management

In General Optimization we use a systematic approach to improve processes, systems, and methodologies with the goal of increasing efficiency and productivity while reducing resource use. Our engineers have a natural talent for examining every aspect of pharmaceutical production, identifying opportunities for improvement, and implementing custom solutions to enhance operational efficiency. This includes a keen evaluation of critical parameters, the integration of state-of-the-art technologies, and the use of advanced analytical methods to drive continuous improvement.

In addition, Project Management is the key to managing complex tasks within the pharmaceutical sector. Our specialists demonstrate exceptional skill in defining project scopes, setting key milestones, and allocating resources wisely. They are skilled in risk assessment and mitigation, ensuring that projects progress smoothly to completion. This proficiency extends to the creation and adherence to effective timelines, ensuring that projects are delivered on time and within budget constraints.

Our engineers have a profound ability to align General Optimization and Project Management with the strict demands of regulatory compliance. They have a keen awareness of the changing landscape of pharmaceutical guidelines and standards, ensuring that optimization efforts and projects are carried out in absolute accordance with current regulatory frameworks.

Along with these core competencies, our engineers have a wealth of practical experience in implementing optimization initiatives and managing a variety of pharmaceutical projects. Their collective expertise spans a wide range of pharmaceutical facilities, including not only traditional API manufacturing processes but also emerging technologies in the field of medical devices.

In conclusion, our consultancy represents an unmatched depth of expertise in General Optimization and Project Management, supported by the high effectiveness of our engineers. Through our expertise, we enable pharmaceutical manufacturers and medical device developers to navigate the complexities of their operations with precision and effectiveness, ultimately leading to the production of therapeutics and medical devices of the highest standard.

We strive to implement simple and operational solutions, and can support the implementation of procedures and training activities that ensure compliance with existing authority requirements and inspection readiness.

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General optimization & project management cases

General optimization & project management profiles

Aseptic production
Cleaning
GMP
Quality
See profile and CV

Reab Jaralla

Process Engineering Consultant
Sema has more than 12 years of experience in the pharmaceutical industry. Working in Xellia with different roles from Compliance specialist, production specialist, GMP documentation specialist, Senior Aseptic processing specialist, has made Sema an experience all round profile around the aseptic processing disciplines.
GMP
Qualification & Validation
Quality
See profile and CV

Sema Oruc

Process Sr. Consultant
Mikael is an experienced person (>15 years) within the pharmaceutical industry who is used to working according to cGMP, working in project form with both leading, driving and being involved in projects and has experience in supporting and leading employees in production.
GMP
Project management
Qualification & Validation
Technology
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Mikael Samuelsson

Process Specialist
John is a multi-disciplined Engineer with much international experience (Switzerland, Germany, Denmark, The Netherlands, Ireland, Australia).
Documentation Generation
Programming
Technology
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John Thornton

CQV/Automation Specialist
Jonas is a self-driven yellow/red Insight profile with the ability to support your engineering needs. Jonas has a degree in Mechanical Engineering, with a speciality in mechanical construction, and a proven track record from a danish machine builder.
Data Driven
Mechanical Engineering/Design
Open minded
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Jonas Højslet

Senior Consultant
Søren has a wide range of competences automation engineering acquired through more than 20 years of experience from Pharma and food and dairy plants. He has a lot of experience working with different process control systems from conceptual design up to handover of plant.
Functional/design
Review and evaluation
Technical Project Management
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Søren Strøm

Senior consultant/Specialist, Automation Engineer
Søren has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects and manufacturing.
GMP
Line & project execution
Personal
Technology
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Søren Wamsler Christiansen

Senior Consultant
Ann-Rikka has 18 years of experience in the pharmaceutical industry. Working in Novo Nordisk A/S at a fermentation and recovery Pilot plant with hands on operation of the equipment and also reporting.
GMP
Project management
Technology
See profile and CV

Ann-Rikka Søgaard

Senior process Engineer

Managing Partner in Process Engineering

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Jonas Højslet

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