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Fill/Finish Process Development Specialist

NL1170

DPS Group Global is currently searching for a Fill/Finish Process Engineer to set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process

Category:
Engineer Process / Food / Dairy Science
Location:
Netherlands
Years of Experience Req.:
> 8 years
Date Posted:
03/06/2019
Days Remaining:
17
Employment Type:
Contract
Education Level Req.:
Bsc or Msc degree

DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are; Pharmaceutical and Biotechnology, Medical Technologies, Oil & Gas, Advanced Technology, Science & Education, Food & Beverage, and Energy.

 

Main purpose:

The main purpose of the Fill/Finish process development specialist is to set up the plans for process development, process characteriz132325.126795ation and process validation activities for the Drug Product manufacturing process. This needs to be done according to the project specific timelines and in compliance with applicable quality and regulatory standards. The related responsibilities focus mainly on late stage process development activities and process performance qualification until planning for Continued Process Verification as part of Life Cycle Process Validation.
In this position you will operate as the interface between DPS and the (external) Drug Product manufacturing sites.

 

Key responsibilities:

  • Accountable for the setup, reporting and timely execution of (outsourced) process development, characteriz132325.126795ation and validation activities
  • Responsible to ensuring close collaboration with the FFP manufacturing specialist and ensuring alignment with project needs through Technical Integrator
  • Responsible as technical subject matter expert in case product or process specific assessments are required
  • Responsible for timely informing/escalating issues as needed
  • Responsible to provide input and review the required documentation which will be included in the filings
  • Responsible for establishing and maintaining a trustful and professional relationship with the external partner (if applicable)
  • In case studies are outsourced, responsible for review of the documentation prepared by the external partner that is required for process development, characteriz132325.126795ation and validation

 

Qualifications:

  • Education:
    • MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
  • Specific Knowledge:
    • In-depth understanding of Life Cycle Process Validation (including late stage process development, process characteriz132325.126795ation, process performance qualification and continued process verification) and GMP manufacturing of vaccines and/or large molecules.

 

Experience:

  • 8+ years of relevant experience
  • Deep understanding of vaccine and/or large molecule process development
  • Deep understanding of GMP drug product manufacturing processes.
  • Proven track record of Life Cycle Process Validation.
  • Strong advantage:
    • Lean 6 Sigma
    • Experience with technology transfers and outsourcing.

 

Additional Details:

Full time preferred, 32 hours discussable. English required, Dutch not needed. Longer-term anticipated. Specific soft skills required: self-sufficient and proactive. Must be able to travel up to 10% and stay abroad for up to 1 week. Feedback on candidates submitted on JNJKJP00035318; no need for experience on equipment validation; we need process validation, someone who understands the procedural steps needed to ensure product quality.

 

Available and interested?

Please send your resume to: [email protected] or give us a call +31(0)715730810

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