Validation Qualification Specialist - Remote Opportunity

About the Role

Join us as a Validation Qualification Specialist in a remote capacity! At Oxford Biomedica (OXB), we are dedicated to changing lives through innovative therapies. Our mission is to empower clients to provide revolutionary treatments to patients worldwide. As a Validation Qualification Specialist, you will play a crucial role in validating systems and processes in accordance with manufacturing best practices, significantly contributing to our mission.

What You'll Do

• Implement qualification and validation operations by establishing policies and strategies.
• Conduct risk analyses and develop validation plans.
• Draft protocols and qualification validation reports.
• Coordinate the work of external providers.
• Lead qualification and validation activities in project mode.
• Investigate deviations related to qualification and validation processes.

Requirements

• Engineering degree or Master’s in Physics, Chemistry, Biology, Metrology, Quality, Automation, or Industrial Computing.
• Significant experience in equipment/utilities qualification, including APS, sterilization, cleaning/disinfection, and sterilizing filtration.
• Proficient in English (minimum B2 level) for reading, writing technical documents, and presenting technical subjects.
• In-depth knowledge of pharmaceutical industry practices related to Quality Assurance and associated validation standards (GMP, ICH, GAMP, PICS/FDA technical guides, risk analysis tools).
• Customer-oriented approach.

Nice to Have

• Experience in a CDMO environment.
• Familiarity with advanced analytical methods.
• Knowledge of regulatory compliance in the biotech sector.

What We Offer

• Attractive compensation package: fixed salary + bonuses, meal vouchers, and competitive health coverage.
• Well-being & balance: 26 vacation days + a minimum of 12 additional rest days (RTT/RFJ), financial contribution to sports activities, and Quality of Life at Work ambassadors on-site.
• Professional development: training programs and growth opportunities.
• Inclusive & collaborative culture: human-sized sites, team cohesion, and supportive management.
• Innovation serving humanity: meaningful and impactful roles.
• Commitment to our values: Responsible, Responsive, Resilient, and Respect.

We want you to be inspired every day. At OXB, we are forward-looking and growing, driven by passion, commitment, and teamwork. Ready to make a difference? Let’s collaborate to change lives!