Validation & Commissioning Engineer
Employment Type:
Contract to Perm
Job Category: Validation
Job Number: 55344664
Compensation: $60-75 / hour
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) environments
- Strong background in sterile manufacturing operations
- Experience with media fills, process simulations, and CPV
- Hands-on experience with equipment qualification (IQ/OQ/PQ)
- Ability to write and execute validation protocols and reports
- Understanding of engineering documentation (P&IDs, specifications, drawings)
- Strong communication and cross-functional collaboration skills
Job 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 simulations
- Develop and author validation protocols and reports
- Support CPV (Continuous Process Verification) and requalification programs
- Perform pre-qualification activities for GMP equipment and systems
- Collaborate with Quality, Manufacturing, and Engineering teams
- Review validation documentation and support QA approvals
- Assist with audit readiness and regulatory inspections
Lead-Level Responsibilities (if applicable):
- Develop commissioning and validation plans and strategies
- Conduct gap assessments, audits, and impact analyses
- Coordinate commissioning activities with vendors and project teams
- Develop traceability matrices and lifecycle validation documentation
- Provide technical leadership and mentorship to junior staff
- Manage multiple validation projects, timelines, and deliverables
Qualifications:
- Bachelor’s degree in Engineering or Science preferred.
- 3–15 years of validation experience in regulated manufacturing environments
- Strong knowledge of sterile manufacturing and GMP compliance
- Experience 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.
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