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Process Engineer Life Science
As Process engineer life science you provide front line expert support for all process-specific issues to production within packaging activities. You ensure execution of processes on-time and continuously improving in quality and productivity.
Your responsibilities include, but are not limited to:
- Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Responsible for maintaining the master manufacturing documents of assigned products.
- Ensure that all critical parameters are within written Instruction.
- Support Product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
- Ensure that all process changes in assigned products are managed through appropriate change control procedure.
- Ensure creation of production procedures.
- Act as Subject Matter Expert (SME) for the product and process knowledge.
- Collect data for ongoing process verification, support product steward in tracking and evaluation of product performance and implementation of CAPAs.
- Perform first line evaluation of product and process related issues.
- Maintain processes at inspection readiness level.
- Support process optimization establishment and new technology introduction.
- Review validation protocols and support the execution of process validations.
- Short-term improvement projects: liaising with all the relevant parties on the shop floor to ensure accurate execution.
- Lauch & Transer:
- Responsible for creating the master manufacturing documents of assigned products.
- Be knowledgeable of process design by providing input during process transfer.
- Manufacturing Excellence:
- Execute process improvements and scale-up.
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
- Training: Support technology trainings and education programs for production operators.
Skills and personality
What you’ll bring to the role:
- Education in a scientific field (Bio engineering, Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology,...)
- Fluent in Dutch and good knowledge of English
- +3 years’ experience in process support on the shop floor of GMP pharma manufacturing
- Proven process understanding (Pharma, GMP, Regulatory aspects) and/or experience in fields as validation and quality
- Strong communication skills, startup mindset, analytical and critical mindset.
- Biotech experience
- Aseptic knowledge
+- 5 year to 10 years
Submit your CV
Please submit your CV through the form below and we will contact you shortly.