• 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
  • Validation Engineer – Athlone

    Role Purpose:

     

    • The Validation Engineer will design, coordinate and execute validation activities in support of the start-up manufacturing facility, and will be responsible for on-going re-validation of equipment and processes.
    • The Validation Engineer reports to the Technical Services Manager.

     

    Duties:

     

    • Develops and writes commissioning, qualification and validation documents following established standards and templates, including but not limited to the following:
    • 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).
    • Provide technical assistance on current US FDA and EU validation requirements for aseptic processing and sterilisation.
    • 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 and Summary Reports
      • Standard Operating Procedures
      • 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).
    • Provide technical assistance on current US FDA and EU validation requirements for aseptic processing and sterilisation.
    • 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/ re validation plans
      • Review/approve execution of the validation/re validation plans
      • Ensure that the validation status of equipment and systems are in compliance with cGMP 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.

     

    Education & Qualifications Required:

     

    • Bachelor’s Degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical) Further qualifications (e.g. Masters) preferred.
    • At least 12 years relevant experience in a pharmaceutical manufacturing environment, with at least 6 years’ experience in a comparable Validation Engineering role.
    • Must have experience working in a sterile manufacturing environment.
    • Ophthalmic manufacturing experience a plus.
    • Requires prior experience performing validations of multiple systems and equipment in a time-sensitive start-up program.
    • Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
    • Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.
    • Knowledge of leveraging test data from early stage project testing into later stages (e.g. FAT into SAT/IOQ)
    • Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9).
    • Computer skills (Spreadsheets, Word Processing, Visio, 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.
    • DoE knowledge desirable.
    • Strong communication and interpersonal skills.
    • Highly motivated with ability to work effectively with multidisciplinary teams or independently.
    • Strong team player.
    • Good proactive approach & manner
    • Knowledge and capability to perform validations of automated systems

     

    To Apply

     

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

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV