Job Summary:
An exciting opportunity has arisen for an experienced C&Q Engineer to join a well-established and highly regarded biopharmaceutical manufacturing organisation based in the Southeast of Ireland on an initial 12-month contract. This role will support commissioning, qualification, and validation activities across manufacturing equipment, utilities, facilities, and laboratory systems as part of ongoing operational and capital projects within a GMP-regulated environment.
Key Responsibilities
- Execute commissioning and qualification activities for equipment, utilities, facilities, and laboratory systems.
- Prepare, review, and approve qualification documentation, including IQ, OQ, PQ, risk assessments, and protocols.
- Support validation lifecycle activities in line with GMP and company procedures.
- Coordinate with Engineering, Operations, Quality, and project teams to ensure timely project delivery.
- Participate in deviation investigations, change controls, and CAPA activities as required.
- Ensure all qualification activities are completed in compliance with regulatory requirements and internal quality standards.
- Provide technical support for site CAPEX and continuous improvement projects.
Requirements
- Degree (or equivalent qualification) in Engineering, Life Sciences, or a related technical discipline.
- Experience in a Commissioning & Qualification (C&Q), Validation, or Engineering role within the pharmaceutical, biotechnology, or other regulated manufacturing industry.
- Strong knowledge of GMP regulations and qualification lifecycle activities.
- Experience qualifying manufacturing equipment, utilities, facilities, or laboratory systems.
- Excellent communication, organisational, and stakeholder management skills.
Desirable Experience
- Laboratory systems qualification experience.
- Qualification of autoclaves.
- Clean utilities commissioning and qualification, including Purified Water (PW), Water for Injection (WFI), Clean Steam, and Process Gases.
- Experience supporting CAPEX projects within GMP-regulated environments.
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