Find & Apply For Validation Engineer Jobs in Lincoln, Massachusetts

3-6+ Month Contract M-F Onsite Overview We are seeking a Senior Validation Engineer with strong experience in the medical device industry to support validation and remediation initiatives. The ideal candidate will have hands-on experience developing and executing validation protocols, particularly Test Method Validation (TMV) and Measurement System Analysis (MSA), along with a strong understanding of

IQ/OQ/PQ

activities. Key Responsibilities Lead and support validation and remediation projects within a medical device manufacturing environment. Develop, review, and execute IQ, OQ, and PQ protocols and reports. Perform and support Test Method Validation (TMV) activities, including Measurement System Analysis (MSA). Evaluate measurement systems for accuracy, repeatability, reproducibility, and suitability for intended use. Develop validation strategies, protocols, acceptance criteria, and final reports in accordance with applicable procedures and regulatory requirements. Investigate validation issues, deviations, and failures and support appropriate corrective actions. Work cross-functionally with Quality, Manufacturing, Engineering, R&D, and Operations teams. Support remediation activities, including identifying validation gaps, assessing existing documentation, and implementing corrective actions. Ensure validation activities comply with FDA, GMP, ISO, and medical device quality system requirements. Maintain accurate and complete validation documentation and provide technical support during audits and inspections. Review existing validation documentation and recommend improvements where necessary. Required Qualifications Bachelor's degree in Engineering, Science, or a related technical discipline. Senior-level experience in Validation Engineering within the medical device industry. Proven experience supporting or leading remediation projects. Strong experience with Test Method Validation (TMV) and Measurement System Analysis (MSA). Hands-on experience writing and executing

IQ/OQ/PQ

protocols. Strong understanding of validation principles, documentation, and regulated manufacturing environments. Experience working within FDA/GMP/ISO-regulated medical device environments. Strong technical writing, problem-solving, and cross-functional communication skills. Preferred Qualifications Experience with validation of manufacturing processes, equipment, test methods, or measurement systems. Experience with deviations, CAPA, nonconformances, and root-cause investigations. Experience supporting FDA or notified-body audits. Familiarity with statistical tools and data analysis used for validation and MSA activities. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

GRPA Pay:

$55.00 - $75.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance People with a criminal record are encouraged to apply

Work Location:

In person