We are hiring on behalf of a leading global pharmaceutical CDMO with operations across Europe, the US, and Asia. With over 60 years of innovation in drug substance and product development, this company is recognized for its strong technological capabilities and high-quality standards.

As part of the Automation team, the Qualification & Validation Specialist will ensure GMP compliance across automation systems and computerized processes. This role is key to supporting site-wide validation activities and aligning quality practices across global sites.

Key Responsibilities:

• Support qualification and validation of automated systems, ensuring cGMP compliance
• Develop and approve URS/DQ/IQ/OQ/PQ documentation for new or modified systems

• Align validation methodologies across Engineering, Automation, and Production teams.

• Manage validation-related deviations, CAPAs, and change controls.

• Participate in internal/external audits and regulatory inspections.

• Collaborate with multidisciplinary teams on validation strategies for equipment and computerized systems (DCS, PLC, stand-alone software).

• Develop and maintain validation procedures and testing documentation in line with industry regulations (GAMP, ISPE).

Requirements:

• Degree in Engineering or a Scientific discipline.

• Minimum 3 years’ experience in equipment qualification and validation within the pharmaceutical sector.

• Strong knowledge of cGMP and industry guidelines (ISPE, GAMP).

• Confident communicator with the ability to work independently and interface with regulators, clients, and cross-functional teams.

If you are interested, apply immediately as interviews begin next week.

Posted On: Tuesday, April 29, 2025