site found HR One - Executive search and project staffing

Job opportunities All vacancies

Process Engineer Life Science

Job description

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:

  • Stewardship:
    • 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.
  • Validation:
    • 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.

 

Desirable requirements:

  • Biotech experience
  • Aseptic knowledge
Contract

Executive search

Experience

+- 5 year to 10 years

Education

Higher Education

Languages

Dutch

Sector

Pharmaceutical industry

Region

Puurs

Job type

Full-time

 
 

Submit your CV

Please submit your CV through the form below and we will contact you shortly.

 

HOW WE CAN HELP

Drop by for
coffee