Job Description

  • Employment Type: Contract
  • Job Location: Carlow
  • Date Posted: Posted 4 months ago
  • Salary:DOE

Summary:
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.

Responsibilities:

  • 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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