Validation Engineer

Job Description

Job Description

Title: Validation Engineer – $60–$75/hr – 4 Openings!

• Location: Boston, MA
• Job Type: Contract (open-ended contract)
• Pay Rate: $60–$75/hr (W2 ONLY - must be US Citizen or Perm Resident)
• Job ID : bh17870

4 Immediate Openings – Help Shape the Future of Cell & Gene Therapies!

Are you a detail-oriented Validation Engineer with a passion for innovative science and cutting-edge facilities? Ready to work in dynamic environments where your expertise drives life-changing breakthroughs? Join one of the most exciting names in biotech, supporting validation efforts at state-of-the-art cell and gene therapy sites in Boston and Cambridge!

We’re hiring FOUR Validation Engineers to support a growing team on key commissioning, qualification, and validation (CQV) activities across GMP manufacturing and analytical lab environments. This is your opportunity to contribute to a world-class operation while growing your own skill set in one of the most innovative therapeutic spaces.

What You'll Do:

• Author and execute URS, IQ, OQ, and PQ protocols in compliance with GDP and cGMP

• Support validation of analytical instruments and automated manufacturing equipment

• Conduct analytical instrumentation qualifications per USP <1058>

• Perform automation assessments for 21 CFR Part 11 compliance

• Partner cross-functionally with QA, IS, EHS, and vendors to schedule and execute validation

• Support aseptic process simulations, process performance qualifications, and more

• Develop and validate sterilization cycles when needed

• Ensure all documentation meets Vertex SOPs and regulatory standards

What We're Looking For:

• 5–8 years of validation experience in GMP environments

• Experience with automated equipment, analytical instrument qualification, and CQV best practices

• Bachelor's degree in Engineering or related discipline

• Familiar with industry standards: GMP, GAMP, USP, ISO, 21 CFR Part 11, ANSI

• Ability to adapt quickly in fast-paced environments

• Flexible to support off-shift hours (nights/weekends as needed)

• Team-focused, solution-oriented mindset

Why Apply?

• High-impact work supporting life-saving therapies

• Competitive pay : $60–$75/hr (W2 - must be US Citizen or Perm Resident)

• Multiple openings mean more chances to get your foot in the door

• Work at cutting-edge facilities in the heart of Boston’s biotech scene

• Gain experience with a globally recognized innovator in gene and cell therapies

Apply today and take the next step in your Validation career!

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Company Description

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.