• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • CQV Engineer – Wicklow

    Role Purpose:

    • Support the construction management and qualification of an ongoing project.
    • The project involves upgrades and installation of new equipment associated with an existing API facility.
    • It will involve ties in to existing or installation of new glass lined reactors, receivers, holding tanks, centrifuges and dryers for the manufacture of a new pharmaceutical.
    • There will be extensive piping, building services (HVAC), new utilities and extensions to existing utilities, together with an upgrade to the automation system.

    Duties:

    • Develops and writes commissioning, qualification and validation documents following established standards and templates.
    • Performs and assists with execution of validation protocols (IQ, OQ, PQ) associated with the manufacturing facility.
    • Performs walk-down and verification of system drawings (i.e., P&IDs, as-builts, etc).
    • Management of the development and execution of IQ, OQ and PQ activities.
    • Ensures projects are managed in conjunction with all regulatory requirements (Health & Safety, cGMP, construction, environmental etc).
    • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
    • Management of validation documentation through: Commissioning Test Scripts, Qualification Validation Protocols, Summary Reports, Risk Assessments, Specifications (URS), FATs / SATs.
    • Performs and assists with execution of validation protocols (IQ, OQ, PQ) associated with the start-up, and with the on-going re-validation of equipment and processes in the manufacturing facility.
    • Performs walk-down and verification of system drawings (i.e., P&IDs, as-builts, etc) Management of the development and execution of IQ, OQ and PQ activities.
    • Ensures projects are managed in conjunction with all regulatory requirements (Health & Safety, cGMP, construction, environmental etc).
    • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
    • Management of validation documentation through: Approval and implementation of changes to relevant systems and assist in generating validation plans.
    • Review/approve execution of the validation plans.
    • Ensure that the validation status of equipment and systems remain compliant at all times.
    • Responsible for review of all design deliverables from the Engineer including drawings, datasheets, specifications and engineering lists.
    • Point person for review for all associated vendor packages.
    • Liaise with Engineers in relation to construction readiness and a schedule for systems/equipment within areas of responsibility.

     

    Minimum Qualifications and Experience:

    • Bachelor’s Degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mechanical).
    • Minimum of 7 years’ experience working in a similar role within a high volume, pharmaceutical manufacturing environment.
    • Strong technical knowledge of API manufacturing techniques and procedures.
    • Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.
    • Computer skills (MS Office, Microsoft Project)
    • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies.
    • Strong analytical skills, documentation skills and research skills.
    • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
    • Strong understanding of pharmaceutical industry regulatory requirements.
    • Good communication and interpersonal skills.
    • Highly motivated with ability to work effectively with as part of a team or independently.
    • Deep understanding of quality requirements

     

    To Apply:

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
    recruitment@prochem.ie

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.