Job Details

Job Description Job Description Job Title: Validation & Commissioning Engineer Location : Greensville, NC Hire Type: Contract, Onsite Target Pay Rate: $60.00 - $75.00/hour (W2) Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), ESOP Must-Have Skills: 3–15 years of validation experience in regulated (GMP) environmentsStrong background in sterile manufacturing operationsExperience with media fills, process simulations, and CPVHands-on experience with equipment qualification (IQ/OQ/PQ)Ability to write and execute validation protocols and reportsUnderstanding of engineering documentation (P&IDs, specifications, drawings)Strong communication and cross-functional collaboration skillsJob Summary: Seeking multiple Commissioning, Qualification, & Validation (CQV) Engineers to support sterile manufacturing operations in Greenville, NC. This role focuses on media fills, process validation, continuous process verification, and ongoing requalification programs within a GMP-regulated environment. Candidates will support both execution-level validation activities and, for senior-level resources, commissioning strategy, project leadership, and cross-functional coordination. Job Duties: Execute and support media fill activities and process simulationsDevelop and author validation protocols and reportsSupport CPV (Continuous Process Verification) and requalification programsPerform pre-qualification activities for GMP equipment and systemsCollaborate with Quality, Manufacturing, and Engineering teamsReview validation documentation and support QA approvalsAssist with audit readiness and regulatory inspectionsLead-Level Responsibilities (if applicable): Develop commissioning and validation plans and strategiesConduct gap assessments, audits, and impact analysesCoordinate commissioning activities with vendors and project teamsDevelop traceability matrices and lifecycle validation documentationProvide technical leadership and mentorship to junior staffManage multiple validation projects, timelines, and deliverablesQualifications: Bachelor's degree in Engineering or Science preferred.3–15 years of validation experience in regulated manufacturing environmentsStrong knowledge of sterile manufacturing and GMP complianceExperience with validation lifecycle documentation and execution (IQ/OQ/PQ)Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.