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CEO at Impel Talent, Space Enthusiast, Investor, & Host of Podcast ️ Breaking the Chain
Impel Talent is hiring on behalf of a leading global pharmaceutical CDMO with state-of-the-art operations across Europe, the U.S., and Asia. With over 60 years of innovation in drug substance and drug product development, this company is known for its advanced technology platforms, rigorous quality standards, and global integration.
As part of the Automation team, the Qualification & Validation Specialist will ensure compliance with GMP regulations for automated systems and computerized processes, supporting site-wide validation strategies and alignment across global facilities.
• Drive qualification and validation activities for automation and computerized systems (DCS, PLCs, standalone software)
• Review and approve URS, DQ, IQ, OQ, PQ documentation
• Ensure cGMP compliance across all validation phases and maintain strict adherence to ISPE and GAMP guidelines
• Support deviation investigations, CAPAs, change control, and continuous improvement initiatives
• Lead and support regulatory inspections, customer audits, and internal assessments
• Promote harmonization of validation procedures across engineering, automation, and production teams globally
• Collaborate with QA, Engineering, and IT teams to ensure systems are validated and compliant throughout their lifecycle
• Degree in Engineering or a Scientific discipline
• 3+ years of hands-on experience in equipment qualification and computerized system validation in the pharmaceutical industry
• Strong knowledge of GxP, GAMP, ISPE guidelines, and regulatory expectations
• Excellent communication and documentation skills, with the ability to interface confidently with internal teams, regulators, and clients
• Proactive, autonomous, and quality-driven professional who thrives in cross-functional environments
Nice to Have
• Experience supporting multi-site validation strategy alignment
• Exposure to lifecycle validation frameworks and audit readiness
Location: EU-based site (Relocation support available for the right candidate)
Note: This is a confidential search conducted by our talent advisory team. Only shortlisted candidates will be contacted.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering, Manufacturing, and Production
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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