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    CQV Engineer - Boston, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Boston, United States

    3 weeks ago

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    Description
    Job description:
    • Comfortable working at a plant undergoing remediation activities amid a challenging startup of a new manufacturing line.
    • Self-starter who can accept/follow direction but won't passively wait for progress.
    • Min. 5 years' experience in equipment/software validation in a pharmaceutical environment.
    • Bachelor's degree in science or engineering.
    • Ability to perform effectively in a team-oriented environment with members from engineering, manufacturing, quality, and validation.
    • Good communication skills for interacting with change owners, subject matter experts, team members and protocol approvers.
    • Good technical writing skills. Great attention to detail, ability to proofread and edit documents.
    • Open to working overtime, weekends or holidays when needed to meet deadlines or based on equipment availability.
    • Must be familiar with cGMPs, FDA and pharmaceutical guidelines.
    • Must be familiar with the validation life cycle, and integrated commissioning & qualification Approach.
    Job Key Skills:
    commission, qualification, validation, CQV, DQ, FATs, SATs, IQ, OQ, PQ, PVPs, URs, RTMs, CPPs, VPPs, Project Validation Plans, Lead qualification processes, Project Managers, Project Leads, Project Specialist, Project Engineers, Project Professionals, Pharmaceutical, Life Science Industry, CQV, MMR, Pharmaceutical, Pharma, Biotech Industry, cGMP, Risk-based commission & qualification, Aseptic processing, Autoclaves, Lyos, Dry Heat Tunnel, HPLCs, FTIRs, GCs, UV Spectrophotometers, TOC Analyzers, Balances, data integrity, Part 11 compliance, HVAC systems, Facility room qualification, utility validation, equipment validation, equipment automation, computer automation, cleaning validation, technical writing, SOPs
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