• 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
  • Process Engineer – Co. Carlow

    Role Summary:


    • A vacancy has arisen for the role of a Process Engineer at our client’s busy pharmaceutical site in Co. Carlow.
    • The successful candidate will serve as Technical Support for commercial manufacturing and new product introduction.
    • Product Risk management and quality risk management Product SME; Management of change.


    Core Duties and Responsibilities:


    • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
    • Provide technical input into quality notification by authoring/reviewing/approving investigations.
    • Execution of equipment/qualification validation programs; including re-qualification and re-validation
    • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
    • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
    • Statistical data analysis to support development and commercialisation batches.
    • Support continuous improvement through Lean Six Sigma methodologies.
    • Leading and active participation in projects, system failure investigations and investigation reports,
    • Execution/development of change controls
    • Contribution to Kaizen events as appropriate.
    • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
    • Implement subsequent corrective action through the change management system.
    • Serve as technical engineering representative for internal technical group discussions and represent technical site Operations at global technical forums.
    • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
    • 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 action, participate in audits and inspections and proactively highlighting any issues around compliance.
    • Work collaboratively to drive a safe and compliant culture on site.
    • May be required to perform other duties as assigned.


    Minimum Qualifications and Experience:


    • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
    • Typical Minimum Experience: 5+
    • Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting
    • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
    • Understand the specific responsibilities of all departments as they relate to ones own department, understanding the business processes ones department supports
    • Customer service and Vendor liaison; progressive people management skills
    • Strong influencing, conflict resolution and trouble shooting skills
    • Demonstrable analytical, systematic problem-solving and negotiation skills
    • Training skills
    • Strong change management and project management skills
    • Risk management skills
    • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
    • Report, standards, policy writing skills required
    • Equipment and process validation
    • Sterile filling processes and equipment
    • Proficiency in Microsoft Office and job related computer applications required
    • Lean Six Sigma Methodology experience desired
    • Data analysis experience required


    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

    Click here to submit your CV

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