CQV Engineer

2 weeks ago

Boston, United States Katalyst Healthcares and Life Sciences Full time
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

  • CQV Engineer

    2 weeks ago

    Boston, United States PES International Full time

    CQV Engineer Pharmaceutical & Life Sciences Company: PES International Location: Boston, MA Compensation: Commensurate with Experience About this opportunity: PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge based in these specialist areas from...

  • CQV Engineer

    2 weeks ago

    Boston, United States PES International Full time

    Job DescriptionJob DescriptionCQV Engineer Pharmaceutical & Life Sciences Company: PES International Location: Boston, MA Compensation: Commensurate with Experience   About this opportunity:  PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge...

  • CQV Engineer

    5 days ago

    Boston, United States PES International Full time

    Job DescriptionJob DescriptionCQV Engineer Pharmaceutical & Life Sciences Company: PES International Location: Boston, MA Compensation: Commensurate with Experience   About this opportunity:  PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge...