Job role: Process Validation Engineer (GMP)
About the Role:
A global leader in biotechnology is seeking a highly skilled Process Validation Engineer to join the Manufacturing Science and Technology (MSAT) Team in Geel on a 1-year contract. In this role, you will play a critical part in ensuring life cycle process validation (LCPV) for both New Product Introduction (NPI) and commercial products (LCM). Your expertise in process validation and GMP compliance will directly contribute to the robustness, quality, and reliability of manufacturing processes.
Key Responsibilities:
* Prepare and update Lifecycle Process Validation (LCPV) documentation and CPV procedures.
* Act as gatekeeper for proposed changes and prioritize process validation projects.
* Perform impact assessments for proposed changes and follow through on assigned actions.
* Initiate and implement process improvements for validation procedures and documentation.
* Ensure adherence to cGxP, GMP, and compliance standards throughout all validation activities.
* Report deviations, incidents, and propose improvements for compliance and safety.
Requirements:
* Master’s degree in (Bio)Sciences, Life Sciences, or related field.
* Strong expertise in API manufacturing processes and validation methodologies.
* Knowledge of statistics and ability to apply data-driven decision making.
* Solid understanding of Quality & Compliance / Regulatory (GMP) requirements.
* Project management, planning, and coordination skills.
* Strong interpersonal skills with ability to manage complexity, deadlines, and change.
* Fluent in Dutch and English (written and spoken).
* Preferably familiar with production and data systems such as eLIMS, truVAULT, COMET, PRX, CRB, SAP, PASx, Minitab, CPV Automation.
Practical’s:
* Location: Geel, Belgium (On-site presence required)
* Duration: 12 months (1-year contract)
* Start Date: ASAP
* Work Model: Full-time, On-site
Interested or know someone who might be?
Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.