Process Validation Engineer

Our client, a leading organization in the life sciences sector, is seeking a professional to ensure manufacturing processes are validated, documented, and maintained in compliance with global standards. This role involves collaborating across departments to validate new and existing processes, supporting product introductions, and maintaining a validated state throughout the lifecycle.

• Draft, review, and update process validation documentation including protocols, reports, risk assessments, and validation master plans.
• Plan and execute validation activities such as Process Performance Qualification (PPQ) and Continued Process Verification (CPV).
• Define and apply sampling plans and statistical approaches to demonstrate process consistency and capability.
• Support the introduction of new products, processes, or equipment into the validation program.
• Assess validation impact for proposed process changes through the change control system.
• Investigate deviations, out-of-trend results, and process excursions while proposing corrective and preventive actions (CAPA).

• You have a Master’s degree in (Bio)Sciences, Life Sciences, or Chemical/Bioengineering.
• You bring 3+ years of relevant experience in process validation or MSAT within a GMP production environment.
• You possess strong knowledge of validation principles including IQ, OQ, PQ, PPQ, and CPV.
• You have an analytical mindset with knowledge of regulatory frameworks such as Eudralex, ICH, and 21 CFR.
• You possess strong project management and organizational skills with a focus on attention to detail.
• You are fluent in Dutch and English.

Nice to Haves

• Experience with API or biopharmaceutical manufacturing processes.
• Familiarity with Minitab or systems such as LIMS, SAP, or PAS-X.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.