Validation Expert

This Quality role oversees validation activities for transport and CMO-manufactured products, including the creation, review and approval of validation plans, protocols, risk assessments and reports. It covers lifecycle management, assessing the validation impact of change controls, deviations, audit/inspection findings and CAPAs, and supporting process validation and related studies.

The position acts as Quality validation SME for regulatory submissions, audits and inspections, ensuring compliance with GMP, GDP, global standards and international regulations. It requires cross-functional collaboration, participation in product core teams, and representation in internal and external audits. The role is also an active member of Communities of Practice (COP) for Facilities, Utilities & Equipment (FUE), Process Validation, Control Strategy and Comparability.

• Create and promote an enterprise Quality Culture and apply it in all work products.
• Generate, review, approve and execute transport validation plans, protocols, risk assessments and reports.
• Review CMO-generated qualification and validation protocols, data and reports.
• Review and approve external transport validation packages, and provide onsite or remote CMO support during study execution.
• Support lifecycle management for CMO-manufactured products.
• Review and assess the validation impact of change controls, major or critical deviations, audit/inspection findings and CAPAs.
• Review and provide input to annual APQR and Continued Process Verification (CPV) reports, and approve CPV reports.
• Support CPV protocols as requested by EM&S ESTs.
• Support process validation and supportive studies for CMO-manufactured products.
• Act as transport/process validation quality SME for new product submissions, dossier variations and Health Authority questions.
• Ensure validated transport processes comply with GMP and GDP requirements at CMOs and service providers.
• Work within EM&S LM SC product-dedicated teams to ensure validation activities are completed on time and in full.
• Ensure adherence to worldwide regulatory requirements and corporate standards so that internal procedures remain compliant.
• Support CMO audits or inspections as validation quality SME.
• May act as Primary Process Owner, Site Process Owner or back-up within a COP.

Community of Practice (COP) Role

Accountable for implementing the process and tool at local level in line with the standardized, harmonized approach, including communication and change management where appropriate.

Responsible for:

• Being the "Voice of the Customer".
• Providing feedback on roadblocks and difficulties encountered in the COP area.
• Sharing lessons learned from inspections relating to the COP area.
• Proposing improvements to simplify and harmonize the process and tool.
• Sharing successes and best practices with other sites.
• Contributing to the objectives set in the COP roadmap.

Technical

• Appropriate training and expertise in the supported COP area.
• Broad knowledge of risk-based qualification and validation approaches in line with current regulations, internal standards and industry practice.
• In-depth experience in equipment qualification, requalification and shipping validation.
• Expert in the Validation Lifecycle Approach.
• Experience with cGMP, ISO 13485 and MDSAP.
• Strong digital skills.

Professional

• Excellent oral and written English with high attention to detail and accuracy (working with US-based colleagues).
• Strong interpersonal and negotiation skills.
• Well organized, able to manage multiple projects in parallel.
• Project management and presentation skills.
• Team player across functions; enthusiastic, independent and self-motivated.
• Demonstrated ability to make independent decisions and exercise sound judgment and discretion.
• Takes calculated risks and anticipates potential issues.

• 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.