An exciting opportunity has arisen for an experienced HVAC Engineer. Joining a collaborative, high-performing team, you will drive the CQV execution for critical HVAC and cleanroom systems from initiation through to final validation summary reporting for a premier manufacturing facility.
Key Responsibilities
Develop and execute robust Commissioning, Qualification, and Validation (CQV) testing documentation for site HVAC and Cleanroom systems in alignment with safety, quality, and project schedule milestones.
Lead Environmental Monitoring Performance Qualification (EMPQ) protocol execution, including physical sampling, laboratory data review, and analytical data interpretation.
Ensure all GMP cleanrooms, cold rooms, and HVAC equipment comply strictly with local site procedures, global quality guidelines, and EU/FDA regulatory standards.
Proactively identify and categorize CQV risks, generate mitigation action plans, and lead deviation investigations associated with assigned cleanrooms and utilities.
Coordinate seamless site execution alongside equipment vendors, external contractors, laboratories, and internal cross-functional project teams.
Prepare comprehensive validation summary reports and manage project electronic records to maintain full audit readiness.
Skills, Attributes & Experience
Third-level degree (BSc / BEng / MSc) in an Engineering, Scientific, or technical discipline.
3-5 years of hands-on C&Q experience within a regulated sterile drug product, biopharmaceutical, or pharmaceutical environment, encompassing both documentation drafting and physical execution.
Proven background in C&Q for sterile manufacturing HVAC systems, cleanrooms, cold rooms, and integrated automation platforms.
Familiarity with digital validation execution software (e.g., Kneat, Valgenesis) is an advantage.
Strong analytical problem-solving capabilities, robust written and verbal communication skills, and a demonstrated ability to deliver safety-focused, high-quality results within a fast-paced team environment.
