This is an exciting opportunity for a CQV Engineer to join a multinational pharmaceutical company based in Carlow. This role supports the transition of a new sterile manufacturing facility from the project phase to full operation, delivering life-saving products. You'll oversee C&Q deliverables, execute process validation studies, and apply Lean Six Sigma methodologies to improve efficiency.
Key Responsibilities:
Commission and qualify process and laboratory equipment.
Execute process validation for sterile manufacturing equipment.
Assess change control impacts on validated systems.
Lead and participate in process improvement and technology transfer projects.
Prepare, review, and approve technical documents, CAPAs, and validation protocols.
Provide oversight during vendor FAT/SAT and ensure effective issue resolution.
Qualifications:
Degree in Mechanical or Chemical Engineering.
3+ years of experience in pharmaceutical/biotech, with sterile manufacturing C&Q experience preferred.
Strong knowledge of regulatory requirements, GMP, and equipment qualification.
Excellent communication skills and ability to work in multidisciplinary teams.
Preferred Skills:
Experience with sterilization, cleaning validation, and equipment qualification (e.g., autoclaves, VHP decontamination).
Expertise in process validation, including filter validation and CCI studies.
Familiarity with Lean Six Sigma methodologies.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108