Senior C&Q Engineer
A vacancy exists for our client, a global Bio Pharma company based in the midlands for a Senior C&Q Engineer. The successful candidate will have several years’ experience working in the pharmaceutical industry and be able to operate in compliance with HPRA, MHRA, FDA and cGMP requirements. A strong technical knowledge of bio-pharma Process Equipment, Cleanroom, Automation equipment and utilities systems is required for the role.
- Ensure there is a strong safety culture and performance in the execution of C&Q deliverables projects and that appropriate stage gate controls are in place prior to the commencement of C&Q activities.
- Ensures that EPCM has appropriate stage gate approach in place to ensure rigour in allowing systems pass from Construction Completion to Energisation.
- Coordinate a commissioning and qualification programme, incorporating utilities, cleanroom, upstream and downstream manufacturing equipment.
- Represent the Client and Coordinate the efforts of EPCM C&Q Team.
- Assist in the development of C&Q plans and successfully execute them according to established schedule, cost and performance standards.
- Attends and provides inputs to Interactive Pull Planning Workshops with stakeholders to plan out commissioning & qualification activities in a schedule critical project.
- Provide technical support to the EPCM commissioning team throughout the project life cycle.
- Oversee via the EPCM the generation, execution and approval of Commissioning & Qualification documentation.
- Assistance with management of changes in C&Q Phase with inputs to HAZOP and design reviews of proposed changes.
- Manage project changes and ensure all are captured, documented and assessed for Quality / Safety / Cost or schedule impacts.
- Assist with the coordination of design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, personnel, outside contractors and vendors.
- Track and report C&Q progress as required against project deliverables.
Qualifications & Experience:
- Third level degree in a relevant discipline.
- A minimum of7 years of relevant experience in capital projects preferably in Pharm/Bio Pharm.
- Proven level of experience in managing and delivering Commissioning, Qualification & Validation (CQV) activities within the pharmaceutical sector.
- Experience of working in a project environment.
- Ability to sequence critical activities in planning work for C&Q Phase.
- Experience of CSV an Advantage.
- Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
- Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
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