• 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 (NPI/TT) – Athlone

    Role Summary:


    • The Technology Transfer/Process Engineer will provide key technical leadership and support in the areas of new product introduction, development batch planning/execution and product launch activity technical support.
    • The successful candidate will ensure that a TT/NPI plan is developed, and all required documentation is generated to support same.
    • They will work cross functionally with Operations, Quality, Engineering etc. to successfully qualify and validate the new product.
    • The Process Engineer will also support manufacturing process troubleshooting and continuous improvement initiatives as required.


    Core Duties and Responsibilities:


    • Works with manufacturing and quality colleagues as part of a Technical Services team whose shared goal is to realise the safety, quality, delivery, and cost objectives of the site.
    • Leads technology transfer and other development projects from a scoping, technical assessment, and technical management perspective. This includes developing procedures, protocols, plans and risk assessments.
    • Supports international regulatory filings through the authoring or review of relevant submission documents as required.
    • Works with global company and Partner colleagues to meet the launch and supply objectives of the organisation.
    • Provides regular updates to site management on technology transfer project plans, status and risks/mitigations.
    • Responsible for developing and rolling out new systems on site such as Continuous Process Validation (eg CPP trending)

     Secondary Responsibilities:

    • Is part of a process SME team for the company’s products, supporting or leading product related deviations, change controls and CAPAs where required.
    • Supports manufacturing by leading/supporting deviation investigations and is familiar with structured problem solving and root cause analysis.
    • Supports validation activity in process manufacturing areas.
    • Provides training and mentoring to build technical capabilities among teams.
    • Supports capital projects throughout equipment lifecycle.
    • 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.


    Minimum Qualifications and Experience:


    • Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
    • At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years’ experience in a comparable process engineering/technical services role.
    • Experience leading technology transfer projects and supporting product launches would be an advantage
    • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
    • Broad knowledge of NPI with ability to lead or support any NPI into the site.
    • Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
    • Strong analytical skills, documentation skills and research skills – strong attention to detail in generation of technology transfer and other documents.
    • Strong understanding of pharmaceutical industry regulatory requirements.
    • Experience managing key internal and external stakeholders.
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
    • Can operate with low levels of supervision and provide regular and clear management updates.


    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.