CQV Validation Engineer (GMP / Kaye Systems) – Cell & Gene Therapy

Title: CQV Validation Engineer (GMP / Kaye Systems)Location: Greater Boston Area, MA (Hybrid 2–3 days onsite) Employment Type: Contract Status: Accepting CandidatesAbout the role Join a high-impact engineering team supporting commissioning, qualification, and validation activities within a regulated biotech environment. This role focuses on ensuring systems and equipment meet cGMP and quality standards across the project lifecycle.Key ResponsibilitiesExecute CQV (Commissioning, Qualification, Validation) activities for equipment and systemsDevelop and execute IQ/OQ/PQ protocols in a GMP environmentUtilize Kaye Validator and data loggers for thermal validation activitiesCollaborate with cross-functional teams including Engineering, QA, and OperationsEnsure compliance with GMP, GAMP, ISO, ANSI standards and internal SOPsSupport validation lifecycle including documentation, deviations, and change controlsQualificationsBachelor’s degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related field8+ years of experience in CQV validation within GMP regulated industriesHands-on experience with Kaye Validator / data loggersStrong knowledge of GMP, GAMP, ISO standards and validation principlesProven experience executing validation protocols and troubleshooting technical issuesAbility to work independently and adapt in a dynamic project environmentCompensation (MA Pay Transparency):Estimated hourly range: $70–$75/hr (W-2).Final rate within this range will be based on skills, experience, and interview results.