Specialist QA – Equipment Validation

About Our Client Our client is a leading global biotechnology organization focused on developing and manufacturing innovative therapies that improve patients’ lives worldwide. With a strong presence in the Netherlands, their Breda site plays a key role in supporting high-quality manufacturing and distribution activities within a highly regulated GMP environment. The organization is known for its strong quality culture, continuous improvement mindset, and commitment to operational excellence. Employees benefit from an international environment where collaboration, compliance, and innovation go hand in hand.

About the Position We are currently recruiting a

Specialist QA – Equipment Validation . This position is ideal for a QA professional with hands-on experience in equipment validation within a GMP environment who is ready to take the next step in their career. The primary focus will be

equipment validation , particularly within manufacturing environments such as labeling, packaging, and device assembly. Experience in these areas is highly preferred. Alternative backgrounds within GMP-regulated equipment validation (e.g., upstream/downstream or manufacturing equipment) will also be considered.

Responsibilities Provide QA oversight and support for equipment validation activities within GMP manufacturing. Review and approve validation documentation (IQ/OQ/PQ), protocols, and reports. Support change control activities related to equipment, ensuring proper risk assessment and documentation. Act as QA representative in risk management activities (e.g., FMEA). Collaborate closely with Engineering, Operations, and other Quality functions. Support investigations and ensure compliance with internal quality standards and regulatory requirements. Contribute to continuous improvement of validation and quality processes.

Requirements Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, or a related technical field. Approximately 3–6 years of experience within a GMP-regulated environment Strong experience in

equipment validation

(key requirement). Experience with labeling, packaging, or device assembly equipment is highly preferred. Alternative backgrounds in manufacturing equipment validation (e.g., upstream/downstream processes) may also be considered. Familiarity with GMP requirements and risk management tools (e.g., FMEA). Knowledge of computer system validation (Annex 11 / Part 11) is a plus. Strong analytical skills and a structured, detail-oriented working style. Good communication skills and ability to work cross-functionally.