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    Associate DP MSAT Engineer - Dublin, Ireland - Regeneron Pharmaceuticals, Inc

    Regeneron Pharmaceuticals, Inc
    Regeneron Pharmaceuticals, Inc Dublin, Ireland

    1 week ago

    Regeneron Pharmaceuticals, Inc background
    Full time
    Description

    In this role you will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities. You will be hands-on solving issues during technology transfer and cGMP start-up and take ownership for providing floor support during operations of off-site manufacturing. This role is responsible for reviewing process data to ensure operational consistency after the processes are successfully transferred and also providing investigation support.

    As a DP MSAT Engineer a typical day might include, but is not limited to, the following:

  • Providing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution
  • Act as the technical lead, with the support of cross-functional teams, for technology transfer
  • Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
  • Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.)
  • Assisting with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations
  • Trending process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations
  • Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities
  • Supports development of sampling plans for GMP batches related to lot release, stability and characterization
  • Works with Manufacturing to ensure robust procedures are utilized for operation of equipment
  • Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
  • Travels to contract manufacturers or business partners, as required, up to 25-50%

    • This role might be for you if you:

  • Demonstrate technical knowledge in drug product manufacturing, product development and validation
  • Possess knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
  • Have strong project management and negotiation skills
  • Demonstrate excellent interpersonal, and communication skills
  • Have strong problem-solving abilities

    • To be considered for this opportunity you should have a BS/BA in engineering or equivalent combination of education and experience.

    Engineer: Requires BS/BA in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.

    Senior Engineer: Requires BS/BA in engineering and 5 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.

    #IREADV #JOBSIEPR #LI-Onsite

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