Process Engineer - Lexington , MA 02421 (Hybrid)

Alpha Business Solutions

  • Lexington, MA
  • 30+ days ago
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    Skills

    • Change Controlunmatched
    • Column Chromatographyunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Data Processingunmatched
    • Identify Issuesunmatched
    • Manufacturingunmatched
    • Manufacturing Operationsunmatched
    • On Callunmatched
    • Operational Auditunmatched
    • Operational Supportunmatched
    • Operations Processesunmatched
    • Process Engineeringunmatched

    Description

    Title: Process Engineer
    Location:  Lexington , MA 02421 (Hybrid)
    Duration: 6+ Months (Possible extension)

    Job Title : Process Engineer / Sr. Process Engineer, Downstream Process Sciences, MSAT
    Worker Location : 400 Shire Way, Lexington, MA 
    Work Arrangement : Hybrid, 3 days on site and 2 days remote per week

    Job Description (include education requirements and years of experience needed)
    Support ongoing purification operations on the manufacturing floor, including Capture step operations, filtration (NF, UF/DF)unit operations, chromatography column performance/integrity and drug substance formulation/bottling
    Troubleshoot process issues
    Monitor and evaluate process operation data for downstream operations
    Provide on-call coverage on a rotation to support MFG operation
    Collaborate with manufacturing staff to find ways to continuously improve the consistency and robustness of process operations
    Support Quality System with consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate

    Education and Experience
    B.S. with minimum 6 years of relevant industry experience (downstream PD or MSAT preferred)
    M.S with minimum 3 years of relevant industry experience (downstream PD or MSAT preferred)

    Numbers & Facts

    LocationLexington, MA

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