• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Validation Engineer – Co. Waterford

    Role Summary:

     

    • A new opportunity has arisen for a Validation Engineer at our client’s biopharmaceutical facility in Co. Waterford.
    • The purpose of this position is to be the subject matter expert in the client’s Fill Finish validation operation and be a recognised expert in this industry.
    • S/he will design, coordinate and execute validation activities in support of the start-up of the manufacturing facility, and will be responsible for on-going re-validation of equipment and processes.

     

    Core Duties and Responsibilities:

     

    • Develops and writes commissioning, qualification and validation documents following established standards and templates, including but not limited to the following:
    • Commissioning Test Scripts
    • Qualification / Validation Protocols and Summary Reports
    • Standard Operating Procedures
    • Risk Assessments
    • Specifications (URS)
    • Trace Matrix (TM’s) / Reliability Trace Matrix (RTM’S)
    • 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.
    • Analyse analytical and in-process data for statistical control
    • Present validation approach and study results to peers and managers
    • 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 company and 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 compliant to cGMP.
    • Present and defend validation studies during regulatory inspections
    • Management of validation documentation through:
      • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
      • Review/approve execution of the validation/revalidation plans
    • 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

     

    Qualifications and Experience:

     

    • 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.
    • Requires prior experience performing validations of multiple systems and equipment in a time-sensitive start-up program.
    • Strong technical knowledge of aseptic manufacturing techniques.
    • 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).
    • Strong analytical skills, documentation skills and research skills.
    • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
    • Ability to effectively prioritise and manage a diversified workload, often to tight deadlines.
    • Strong understanding of pharmaceutical industry regulatory requirements.
    • Strong communication and interpersonal skills, a professional approach with excellent written and verbal communication skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
    • Strong team player.
    • Knowledge and capability to perform validations of automated systems.
    • The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.

     

    To Apply: Quote – PE22036

     

    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

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