In this exciting role, you will be part of the Commissioning & Qualification (C&Q) group within an innovative cell therapy department. Your mission is to ensure conclusive, documented evidence that all equipment and utilities are and remain correctly qualified. You will act as 'Technical Owner' and thus contribute to ensuring that processes and products always comply with the strictest regulations and company standards within an international pharmaceutical company.
What you will do.
- Coordinate assigned qualification trajectories and act as technical owner of qualification files for equipment within the cell therapy organization.
- Perform detailed technical evaluations for changes, projects, deviations, and investigations. Accurately record and follow up on all actions and statuses in TrackWise.
- Review and approve qualification documents (e.g., URS, DQ, IQ, OQ, PQ, VMP) and test results from fellow engineers, in close collaboration with the QA validation team.
- Participate in project and planning meetings, coordinate schedules and necessary test materials with involved departments, and escalate in a timely manner where necessary.
- Manage and optimize overarching C&Q processes, contribute to internal improvement initiatives, and support audits and inspections.
- Ensure careful handover in case of absence, support specialist colleagues as a backup, and accurately record worked hours.
- Guarantee strict compliance with GMP guidelines and continuously strive for high-quality equipment dossiers.
- Keep knowledge of current international laws and regulations regarding process equipment up-to-date and proactively identify gaps or improvement opportunities (Kaizen).
- Timely follow up and complete all mandatory training within the set deadlines.
- Act as content process owner within your domain.
- Provide constructive feedback to fellow engineers to promote the overall quality of work.
- Support the onboarding and training of new team members and assist with introductory training.
Profile
- Education: Bachelor's or Master's degree (or equivalent by experience) in a relevant scientific or technical field.
- Experience: 2 to 4 years of relevant work experience, preferably in a regulated pharmaceutical (GMP) or bio-engineering environment. Experience with process equipment qualification is a strong asset.
- Technical knowledge: Familiar with validation documentation and C&Q processes. Knowledge of systems such as Trackwise is a big plus.
- Skills: Extremely accurate, critical eye for quality, strong communication and coordination skills.
- Availability: Willingness to work on-site.
How to apply
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