Commissioning & Qualification Engineer

We are looking for a Commissioning & Qualification Engineer to support GMP compliance for cleanrooms, HVAC systems, utilities, and critical infrastructure used in the production of parenteral biopharmaceuticals. This role plays a key part in qualifying equipment, facilities, and systems in alignment with EU and US regulatory requirements. Key Responsibilities: Oversee GMP commissioning and qualification of cleanrooms, HVAC, utilities, and associated systems. Ensure all facilities, utilities, and equipment meet qualification standards under EU and US regulations for parenteral products. Prepare, execute, review, and approve qualification documentation in line with internal policies and SOPs.

Manage qualification activities for GMP-relevant systems and equipment. Develop and process critical documentation, including System Impact Assessments, Validation Plans, URS, IQ/OQ/PQ protocols, and final reports. Support and participate in change controls, deviations, and CAPA processes. Lead or contribute to investigations of issues identified during qualification, and implement corrective actions as needed. Qualifications: Technical education (e. g. , Bachelor's degree) in a relevant field. Solid knowledge of GMP practices, including qualification, documentation, change control, and protocol execution (IQ/OQ/PQ). Experience with GMP documentation and issue resolution. What We Offer:

A chance to contribute to meaningful projects that make a real difference in people’s lives. Opportunities within a rapidly expanding, global biopharma company. A diverse, inclusive, and collaborative work culture. A flexible, forward-thinking work environment that encourages innovation. Career growth and internal development support. Company-sponsored events and celebrations. Excellent on-site canteen and coffee house. Wellness benefits and on-site shower facilities. Eco-friendly transport grant for full-time employees.