CQV Engineer

Job Title: CQV Engineer

Location: South Boston and Cambridge, MA ( Fully Onsite )

Employment Type: W2 Only

Duration: 6 Months

Hours: 40 hours per week

Position Overview

The Client is seeking a Validation Engineering Specialist to support Commissioning, Qualification, and Validation (CQV) activities across its Cell and Gene Therapy (VCGT) facilities in South Boston and Cambridge, MA.

The selected candidate will support the qualification of manufacturing equipment, analytical instruments, and automated systems while ensuring compliance with cGMP regulations, industry standards, and internal quality procedures. Responsibilities include developing and executing validation protocols, maintaining compliant documentation, and collaborating with cross-functional teams to support equipment and process validation activities.

The ideal candidate will have hands-on experience in validation or qualification within a regulated pharmaceutical or biotechnology environment, strong documentation skills, and the flexibility to support occasional night and weekend activities.

Key Responsibilities

1. Commissioning, Qualification, and Validation (CQV)

• Develop, author, and execute validation protocols, including URS, IQ, OQ, and PQ.
• Support qualification activities for analytical instruments, manufacturing equipment, and automated manufacturing systems.
• Perform analytical instrument qualification in accordance with USP <1058> and internal Vertex SOPs.
• Conduct automation assessments to verify compliance with 21 CFR Part 11 requirements.
• Support equipment commissioning, qualification, and validation throughout the equipment lifecycle.
• Assist with sterilization cycle development, qualification, and validation activities.

2. Process Validation and Documentation

• Prepare and maintain validation documents in accordance with Good Documentation Practices (GDP), cGMP requirements, and internal procedures.
• Support process validation activities, including Aseptic Process Simulations (APS), Process Performance Qualification (PPQ), material qualification, and sterilization process validation.
• Develop and maintain quality system documentation to support effective validation practices.
• Ensure validation activities comply with applicable regulatory requirements, industry standards, and internal SOPs.

3. Cross-Functional Collaboration

• Coordinate qualification activities, testing schedules, and execution plans with equipment vendors and external partners.
• Collaborate with Manufacturing, Quality, Information Services, EH&S, Global Security, and Engineering/Design teams.
• Support troubleshooting and resolution of equipment qualification and validation issues.
• Coordinate on-site testing and execution activities to ensure safe and timely project delivery.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 1–3 years of experience in validation, commissioning, qualification, or a related technical role within a regulated environment.
• Hands-on experience authoring and executing IQ, OQ, and PQ protocols.
• Understanding of cGMP requirements and Good Documentation Practices (GDP).
• Familiarity with applicable regulatory frameworks and industry standards, including GMP, ISO, GAMP, and ANSI.
• Strong technical writing, organizational, and problem-solving skills.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Flexibility to work occasional nights and weekends based on project requirements.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, or Cell and Gene Therapy manufacturing environments.
• Experience qualifying analytical instruments, manufacturing equipment, or automated systems.
• Familiarity with USP <1058> and 21 CFR Part 11 requirements.
• Exposure to aseptic processing, sterilization validation, or PPQ activities.
• Experience coordinating validation execution with equipment vendors and internal stakeholders.