• 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
  • Process Engineer – Co. Waterford

    Role Summary:

     

    • An exciting opportunity has arisen for a Process Engineer – Drug Product Fill / Finish based at our client’s biopharmaceutical Waterford facility.
    • The purpose of the role is to provide process engineering support to Sterile Fill Finish Drug Product The Tech Transfer process to facilitate the manufacture of commercial and clinical products.
    • The successful candidate will be reporting to the Lead Process Engineer.

     

    Core Duties and Responsibilities:

     

    • Provide process engineering support to Sterile Fill Finish product teams & projects
    • Work cross functionally to establish integrated plans to drive Tech Transfers according to key milestones
    • Define and review equipment specification and associated test documentation for Tech Transfers
    • Develop critical process parameters (CPP’s) and Critical Quality Attributes (CQA’s) according to tech transfer plans (i.e. cycle development, Eng Runs. Etc)
    • Understand and manage critical path activities for Tech Transfers
    • Perform Facility and Process Gap Assessments in the Tech Transfer Process
    • Liaise with vendors on disposable technologies and process integration
    • Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing)
    • Develop new manufacturing processes and technologies for Tech Transfer
    • Strong focus on disciplined root cause analysis
    • Monitor process risk and ensure mitigations are in place as required
    • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
    • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
    • Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
    • Take ownership for quality compliance in all activities under the responsibility of the role.

     

    Minimum Qualifications and Experience:

     

    • Qualified to a minimum of Degree level in engineering or related discipline
    • Minimum 8 years of Process Engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
    • cGMP compliance
    • Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
    • Ability to understand engineering processes through a logical, data driven, hands on approach
    • Use of FMEA, FMECA and Risk assessment techniques
    • Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective
    • Strong report writing skills
    • This role requires good judgment and strong initiative.
    • You need to have the ability to effectively prioritise and manage a diversified workload, often to tight deadlines.
    • You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

     

    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

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