Equipment CQV Engineer

United Pharma; Massachusetts; On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma seeks an experienced Equipment CQV Engineer to execute C&Q activities for GMP manufacturing, laboratory, and facility support equipment. You will hands-on test, document results, and ensure equipment readiness for use by manufacturing and engineering teams in a fast-paced GMP environment.

You will review IQ/OQ protocols, maintain qualification documentation, and collaborate with Quality, Validation, and vendors to keep projects on schedule.

Qualifications

• Experience in CQV/C&Q within a pharmaceutical or biopharmaceutical environment.
• Hands-on IQ/OQ execution 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.

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 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.

Skills

CQV/C&Q Experience

GMP knowledge

GDP knowledge

Equipment qualification testing

Troubleshooting

Documentation review

Cross-functional collaboration

Independent work

Job description

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.