Summary: An exciting opportunity has arisen for a CQV (Commissioning, Qualification & Validation) Engineer to join a fast-growing biotech start-up in South Dublin.
This role will be key in supporting the installation, commissioning, and qualification of small-scale bioprocessing equipment as the company scales its operations.
If looking for a hands-on role in a dynamic start-up environment, where contributing to the development of cutting-edge bioprocessing technology, this is the perfect opportunity.
Responsibilities: Lead commissioning, qualification, and validation (CQV) activities for small-scale bioprocessing equipment.
Develop and execute FAT, SAT, IQ, OQ, and PQ protocols in compliance with regulatory standards.
Work closely with equipment vendors, contractors, and internal teams to ensure seamless installation and startup.
Identify and troubleshoot issues during commissioning and qualification phases.
Ensure GMP compliance and documentation meets industry regulations.
Support risk assessments, deviations, and change control processes.
Collaborate with cross-functional teams, including process engineers and quality teams, to ensure project success.
Qualifications & Experience: Degree in engineering (mechanical, chemical, or related discipline) or relevant experience.
2+ years of CQV experience in biopharma, biotech, or pharmaceutical industries.
Hands-on experience with bioprocessing equipment installation and qualification.
Strong knowledge of GMP, regulatory requirements, and validation principles.
Excellent problem-solving, communication, and organizational skills.
Skills: CQV GMP problem-solving communication skills.
organizational skills