Overview
CQV Engineer (Solution Prep/Formulation Area) - Ireland, Cork - 12 Months Initial Contract.
Our client is undergoing major expansion, supported by substantial investment aimed at increasing its overall manufacturing capacity in the medical device sector.
Recent upgrades include the development of new, state-of-the-art facilities, advanced automation systems, and additional infrastructure enhancements designed to strengthen operational resilience and meet growing global healthcare demands.
With a long-established presence and a highly skilled workforce, the site requires the role of a CQV Engineer to join their project based in Cork.
Responsibilities
Guide CQV activities for solution prep, ensuring timely execution and compliance with industry regulations.
Develop, review, approve and execute the commissioning, installation and qualification protocols ensuring all issues identified during execution are managed correctly, efficiently and in accordance to site / project procedures.
Generate, review and approve Validation Plan, SRA, DQ, URS's etc.
Manage and coordinate Solution Prep equipment commissioning and qualification activities.
Qualifications
Relevant qualification (Degree) and/or relevant experience in biotech / pharmaceutical industry qualifying GXP systems.
Guide CQV activities for solution prep, ensuring timely execution and compliance with industry regulations.
Develop, review, approve and execute the commissioning, installation and qualification protocols ensuring all issues identified during execution are managed correctly, efficiently and in accordance to site / project procedures.
Generate, review and approve Validation Plan, SRA, DQ, URS's etc.
Manage and coordinate Solution Prep equipment commissioning and qualification activities.
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