• 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. Carlow

    Role Summary


    • Our client is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment.
    • The successful candidates will support several aspects of Validation: The roles available will require experienced, energetic and committed engineers in the following areas: Sterilisation – Autoclaves, SIP of vessels; Cleaning – Parts Washer and CIP of vessels; Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Depyrogenation systems; Controlled Temperature Units (CTU) – Temperature/Humidity Mapping; Filter Validation.


    Core Duties and Responsibilities:


    • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
    • Design/Author/Review/Approve/Execute Execution/development of change controls.
    • Resolving technical issues encountered during study execution.
    • Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
    • Technical input into quality notification by authoring/reviewing/approving investigations.
    • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
    • Support continuous improvement through Lean Six Sigma methodologies.
    • Serve as validation representative for cross functional projects and represent the validation team at global technical forums.
    • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
    • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
    • Supporting regulatory audits and submissions as required.
    • Work collaboratively to drive a safe and compliant culture on site.
    • May be required to perform other duties as assigned.


    Minimum Qualifications and Experience:


    • In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
    • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
    • Knowledge of CTU equipment qualification
    • Knowledge of thermal mapping equipment
    • Thermal mapping skills
    • Exception / Deviation Management and Change Control.
    • Demonstratable experience of leading technical related projects.
    • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
    • Evidence of continuous professional development is desirable.
    • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
    • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
    • Report, standards, policy writing skills required.
    • Equipment and process validation.
    • Sterile Fill-Finish processes and equipment.
    • Proficiency in Microsoft Office and job-related computer applications required
    • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
    • Knowledge and experience of the below areas will be considered advantageous
    • Equipment Periodic Validation
    • Equipment Validation Lifecycle
    • Project Management Skills/Qualification
    • Filter Validation & Container Closure Validation
    • Autoclave/SIP Sterilisation Validation
    • Dry Heat Sterilisation
    • Isolator Qualifcation
    • Vial and Syringe Processing Technologies
    • Temperature Mapping
    • Cleaning Validation
    • The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position.


    To Apply: Quote – PE23043


    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

    Click here to submit your CV

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