Process Validation Engineer

The Company  Our client is a global, research-driven pharmaceutical company dedicated to discovering, developing, and manufacturing innovative medicines, vaccines, and animal health products. With a strong focus on quality, regulatory compliance, and scientific innovation, the company operates state-of-the-art manufacturing facilities that produce sterile pharmaceutical products for patients worldwide.

Job Description  We are looking for a Process Validation Engineer to join the team in Boxmeer. This project-based role involves the validation of sterilization processes, specifically addressing issues with filtration systems used in the production of sterile medicines. The ideal candidate will investigate current filtration methods and implement modifications to meet strict sterilization requirements.
Responsibilities   Conduct thorough investigations into existing sterilization and filtration processes.
Modify and optimize filtration procedures to ensure compliance with GMP and sterilization standards.
Write and review validation protocols, reports, and statements documenting procedures and findings.
Collaborate with engineering and production teams to implement process improvements.
Ensure all validation activities align with regulatory and quality requirements.
Support the project from start to completion, which is estimated to last approximately 1 to 1.5 years.
Requirements   Minimum of 5–6 years’ experience in the pharmaceutical industry, with a focus on validation and process improvement.
Strong knowledge of GMP standards, sterilization, and filtration processes, with understanding of aqueous and oily solution chemistry.
Proven experience writing validation protocols, reports, and statements.
Fluent in English; basic Dutch language skills are a plus but not required.
Senior-level experience (P3), with the ability to work independently in a project environment.
On-site availability in Boxmeer; full-time (40 hours/week); maximum one day of remote work.

#J-18808-Ljbffr