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    Process Engineer - Old Toronto, Canada - JobContax

    JobContax
    JobContax Old Toronto, Canada

    2 weeks ago

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    Description

    Are you a Process Engineer/Scientist with 5+ years of drug product experience?


    If you have 5 or more years of experience in areas like drug product formulation, vial/pre-filled syringe filling, or lyophilization, we have a contract role for you based on site in Dun Laoghaire, Dublin.

    If you are interested and have the relevant experience, please forward your CV to for review or call to discuss in confidence.

    Process Engineer/Scientist - Biotech - Dublin


    Our client is a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland, currently undergoing rapid expansion and capital investment.

    This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.

    Process Engineer/Scientist is required to work within the Process Development Commercial Support team. The team provides process and product support to drug product formulation and fill-finish operations as drug product process SMEs.

    1. Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
    2. Key contributor to product and process investigations, responsible for assessing product and process impact.
    3. Leads continuous improvement projects to enhance process performance and productivity.

    Other responsibilities include:

    • Assessing product impact associated with proposed changes to commercial processes under the change control process.
    • Generating product impact assessments related to process excursions and deviations, with reference to product technical documentation.
    • Supporting new product introduction team as a process subject matter expert.
    • Reviewing and approving changes to operating procedures, electronic batch records, and product documentation.
    • Conducting risk assessments and mitigation projects relating to line performance.
    • Performing process gap analysis and developing strategies to close gaps.
    • Conducting data trend analysis for all performance aspects of the area.
    • Troubleshooting performance trends.

    The chosen candidate will work collaboratively within the process teams structure and contribute as a member of cross-functional teams within the local organization and functional team globally.

    Requirements:


    Bachelor's or Masters degree in Engineering, Science, or related discipline with 6 years of experience in a similar role OR PhD and 3 years of directly related experience.

    Key qualifications:

    • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
    • 4-6 years of drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, or lyophilization.
    • Qualification in Lean and 6-sigma methodologies would be an advantage.
    • New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.

    Package: Contract role - Hourly rate €50 - €60 per hour for a minimum 12-month contract.


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