Currently I am looking for a Process Engineer for a pharmaceutical company in Leiden.
The main purpose of the Fill/Finish process development specialist is to set up the plans for process development, process characterization 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 the company and the (external) Drug Product manufacturing sites.
* Accountable for the setup, reporting and timely execution of (outsourced) process development, characterization 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, characterization and validation
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 characterization, process performance qualification and continued process verification) and GMP manufacturing of vaccines and/or large molecules.
- 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.
-Lean 6 Sigma
-Experience with technology transfers and outsourcing.
Are you the enthusiastic Engineer I am looking for? Apply online or to speak to the consultant about this project, contact Niek van Alfen via +31 (0)20 522 1588 or n.vanalfen[at]realstaffing.com.