New

Validation Engineer

Digital Prospectors
United States, Massachusetts, Boston
230 Congress Street (Show on map)
Sep 29, 2025
Position:Validation Engineer Location:Boston, MA (Onsite) Length:6+ months W2 Candidates Only, without Sponsorship, No C2C Job Description:* Our client is seeking a skilled Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities. In this role, you will be responsible for executing validation protocols, qualifying manufacturing and analytical equipment, and ensuring compliance with GMP, GDP, and regulatory standards. The position requires close collaboration with cross-functional teams and external vendors to maintain quality, safety, and operational readiness in a fast-paced cell and gene therapy environment. Essential Duties and Responsibilities (but not limited to): Draft and implement quality system documentation to establish and maintain validation best practices. Author and execute URS, IQ, OQ, and PQ protocols in alignment with GDP guidelines and internal quality standards. Support qualification of analytical instruments, manufacturing equipment, and automated systems. Conduct instrument qualification activities in accordance with USP <1058>. Perform automation assessments to ensure compliance with 21 CFR Part 11. Collaborate with vendors and internal stakeholders to plan and execute test plans and CQV schedules. Partner cross-functionally with information systems, EH&S, security, design teams, and quality to align on validation needs. Support process validation activities, including aseptic process simulations (APS), process performance qualifications, and material qualifications. Develop and validate sterilization process cycles when required. Ensure all validation activities comply with SOPs, global standards, and cGMP guidelines. Promote a "right-the-first-time" culture and maintain strong cross-functional relationships. Qualifications: Bachelor's degree in Engineering or a related discipline. 5-8 years of hands-on validation experience in GMP manufacturing and laboratory environments. Strong background in commissioning, qualification, and validation activities. Familiarity with GMP, ISO, GAMP, and ANSI standards. Demonstrated ability to adapt quickly in a dynamic, fast-paced setting. Flexible availability for off-shift, weekend, or night work as required. Excellent communication and collaboration skills to work effectively with cross-functional teams. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. Come see why DPC has achieved: 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor. Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com