Qualification & Validation Engineer A leading organisation within the life sciences manufacturing sector is seeking a Qualification & Validation Engineer to support validation, qualification, and compliance activities across a GMP-regulated production environment. This opportunity is ideal for professionals with experience in CQV, equipment qualification, process validation, and GMP documentation who are looking to contribute to complex manufacturing and facility projects within a highly regulated setting. Key Responsibilities
Execute qualification and validation activities for manufacturing equipment, utilities, facilities, and production processes.
Prepare and manage qualification documentation, including URS, DQ, IQ, OQ, and PQ protocols.
Support qualification of process equipment, laboratory systems, HVAC systems, clean utilities, cleanrooms, and production assets.
Develop, review, and maintain validation protocols, reports, risk assessments, and traceability documentation.
Participate in commissioning, qualification, and handover activities for new installations, upgrades, and expansion projects.
Investigate and manage deviations, change controls, CAPAs, and validation-related issues.
Ensure activities are conducted in compliance with GMP requirements, Annex 15, GAMP 5 principles, data integrity standards, and internal quality procedures.
Collaborate closely with Engineering, Quality, Manufacturing, Automation, Technical Services, and external partners.
Support internal audits, regulatory inspections, and overall inspection readiness initiatives.
Maintain validation lifecycle documentation, qualification schedules, and validation master plans.
Requirements
Experience in qualification, validation, or CQV within pharmaceutical, biotechnology, CDMO, medical device, or other regulated manufacturing environments.
Strong understanding of GMP regulations and validation lifecycle methodologies.
Hands-on experience with IQ/OQ/PQ execution, validation protocols, risk assessments, and technical documentation.
Knowledge of manufacturing systems, process equipment, utilities, cleanrooms, HVAC systems, or laboratory equipment qualification.
Familiarity with quality systems, including deviations, CAPAs, change controls, and audit support activities.
Understanding of Annex 15, GAMP 5, and data integrity requirements.
Strong analytical skills, attention to detail, and a structured approach to documentation.
Ability to work effectively within multidisciplinary teams and manage multiple priorities.
Professional-level German and good English communication skills are advantageous.
What's on Offer
Opportunity to work within a highly regulated and technically advanced manufacturing environment.
Exposure to large-scale qualification and validation projects.
Cross-functional collaboration with engineering, quality, manufacturing, and technical teams.
Long-term career development within a growing life sciences organisation.