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    Process Improvement Engineer - Solihull, West Midlands, United Kingdom - Asset Recruitment

    Asset Recruitment
    Asset Recruitment Solihull, West Midlands, United Kingdom

    1 week ago

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    Description

    Our client, a leading multi-national Biotech company, is seeking enthusiastic candidates to join their External Manufacturing (ExM) Technical Operation team in two different sites, one located in Co.

    As part of Ex Tech Ops, you will support technology transfers and oversee Large Molecule Drug Substance production at our External Partners (EPs).

    You will engage in various aspects, from facilitating technology transfers to troubleshooting production issues and enhancing process efficiency.

    Lead technical activities for commercial manufacturing processes at External Partners, including change control, process improvement initiatives, performance analysis, and investigating irregular events.

    – Interpret regulatory standards and operational needs, developing standardized practices in coordination with Operations, Quality, and External Partners.
    – Master Batch Records, change controls, protocols, reports) and regulatory filings.
    – Offer on-site support at External Partner facilities for Commercial and Technology Transfer Person-In-Plant Activities.
    – Prepare External Partners for inspections, aligning efforts with Operations, Quality, and Regulatory teams.
    Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or related field.
    – Minimum 4 years of GMP-related experience post-bachelor's degree, specifically in Operations, Technical Operations, Technology, Engineering, or Maintenance.
    – Willingness to travel approximately 25%.
    – Experience in deviation management, change control, equipment support, and/or project management.
    – Demonstrated project management ability, meeting deadlines independently.
    – Statistical expertise, including Proactive Process Analysis and Continuous Process Verification.
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