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Equipment CQV Engineer

Job in Lowell, Middlesex County, Massachusetts, 01856, USA
Listing for: United Pharma
Full Time position
Listed on 2026-09-02
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 90000 - 140000 USD Yearly USD 90000.00 140000.00 YEAR
Job Description & How to Apply Below

We are seeking an experienced Equipment CQV Engineer to support Commissioning & Qualification (C&Q) activities for manufacturing, laboratory, and facility support equipment within a GMP-regulated biopharmaceutical environment. The engineer will be responsible for hands-on protocol execution, equipment readiness, documentation, troubleshooting, and coordination with cross-functional teams and equipment vendors.

Key Responsibilities:

  • Execute Commissioning & Qualification (C&Q) activities for GMP manufacturing, laboratory, and support equipment.
  • Review and execute approved IQ/OQ and equipment qualification protocols in accordance with GMP and site procedures.
  • Perform hands-on qualification testing and accurately document test results following Good Documentation Practices (GDP).
  • Verify equipment installation, functionality, and readiness for manufacturing and engineering use.
  • Troubleshoot qualification execution issues, discrepancies, and deviations and support timely resolution.
  • Review equipment documentation and qualification packages for accuracy, completeness, and compliance.
  • Support equipment commissioning, startup, and qualification activities.
  • Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors to complete activities on schedule.

Required Skills &

Qualifications:

  • Experience in Commissioning & Qualification (CQV/C&Q) within a pharmaceutical or biopharmaceutical environment.
  • Hands-on experience executing IQ/OQ and equipment qualification protocols.
  • Strong understanding of GMP, GDP, qualification practices, and regulatory requirements.
  • Experience with manufacturing, laboratory, or facility support equipment qualification.
  • Strong troubleshooting and problem-solving skills during qualification execution.
  • Experience reviewing and maintaining qualification documentation and equipment packages.
  • Ability to manage multiple qualification activities and meet aggressive project timelines.
  • Strong communication and collaboration skills with Engineering, Quality, Manufacturing, Validation, and vendors.
  • Ability to work independently and provide hands-on support in a fast-paced GMP environment.
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