Validation & Commissioning Engineer

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.