Jonas Christensen

Senior Engineer

Extensive Technology knowledge | GMP documents | Process and equipment lead responsible | Project overview and management | Test and verification

Summary

Jonas has a wide range of competences acquired through 10 years of experience from the Pharma and life science industry through his work for a variety of national and international life science/pharmaceutical/medical device companies both big scale API chemical synthesis and finished product aseptic production.

Jonas has implemented global production strategies, transitioned engineering teams to agile execution models, and ensured full life cycle asset management for new production lines. He has led cross-disciplinary projects totaling 200M+ DKK, managing GMP compliance, change orders, and complex handovers. Additionally, he served as the construction management lead on a warehouse project, overseeing design, scheduling, and implementation under stringent regulatory standards. In earlier roles, he directed large-scale facility operations, managing 50+ staff and high-volume logistics. His strengths lie in driving execution, aligning strategy with operations, and navigating regulated environments.

Special Competences

Process- and equipment lead responsible within the pharmaceutical industry
with a lot of hands-on experience, e.g. in-field testing- and verification.
Technology including extensive knowledge about pharmaceutical big scale
chemical synthesis, HVAC systems and aseptic behaviour/requirements in clean
rooms, and vast all-round technical knowledge of production equipment- and
pharmaceuticals in GMP environment
GMP: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA)
requirements to Qualification and Validation, e.g. SOPs, Protocols, Reports,
Validation deviations
Personal: Curious, Maintain overview for complex tasks, seamless handovers,
open-minded, proactive & solution oriented, adaptive to the customers requirement

Project Experience

Project management support, Clinical Trials Packaging (external freelance consultant)
Engineering- and IT requirement specifications for new packaging lines
Defining, merging and updating lists from existing lines into to new refreshed lists.
Points were e.g. automation, hardware, process/procedures, EHS and safety.
Novo Nordisk A/S, Denmark – 2024
Project management support, API Expansion (external freelance consultant)
SVR based project support and coordination
Construction Control and documentation (VPL, Baseline, SAP, drawings and P&ID)
for Clean- and Black utility, e.g. new liquid Nitrogen tank to supply state-of-the-art
Freeze Dryers.
Novo Nordisk A/S, Denmark – 2024
Aseptic process supporter (external freelance consultant)
Deviation lead investigator
Handling and writing, using A3 tools (systematic problem solving). Primarily related to the filling process, but also environmental-, quality/regulatory (Annex 1)-, and equipment related.
Novo Nordisk A/S, Denmark – 2023-2024
QA Specialist in medical device production (employee)
Release of products (approve batch documentation-, analyses- and certificates
(CoC and CoA)), participation in internal/external audits, handling/facilitation of
Change requests/Deviations and CAPA´s, prepare QMR (Quality Management
Review report), participation in R&D projects ensuring right quality and standards
(ISO 9001 and internals). Project manager (implementation of ISO 13485).
Chempilots A/S, Denmark – 2022-2023
Production Chemist/Specialist in API production (employee)
Review of production batch/report, data handling from R&D and QC, deviation
handling (A3), change handling, updating/drafting of procedures, troubleshooting
(Go-Look-See) and daily support/training. The topics range from equipment-related
(breakdown, maintenance, calibration, operating method, optimization, etc.) to
chemical process (reaction, temperature, pH, safety, etc.) and operator workflows.
Syntese A/S, Denmark – 2021-2022
Validation specialist in API production (employee)
Qualification of equipment and process validation in production, as well as
optimization of facilities. Project manager on new production facility (class D) – with
responsibility for both design of ventilation, airlocks and rooms, workflows and
security, and initial qualification of equipment; 2000 L reactor, centrifuge, drying
cabinets (steam and vacuum), sieve, and the purification plant (2 large HPLC
columns).
Chr. Olesen Synthesis A/S, Denmark – 2020-2021
Ventilation chemist in aseptic production (employee)
Qualification and validation of ventilation equipment (preparation/execution/review
of protocols and reports), maintenance, smoke studies, operational tasks,
support/training, optimization, implementation of authority requirements, audit
presentations, deviation management (A3) and change management.
Novo Nordisk A/S, Denmark – 2015-2019