CQV Validation Lead – GMP Process Engineer (Onsite)

Validation & Engineering Group; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group seeks a Senior Process Engineer CQV Validation Engineer to lead manufacturing process characterization and validation activities. The role focuses on IQ/OQ/PQ execution, equipment qualification, and continuous improvement in a primarily on-site setting with potential limited remote work based on project requirements.

Candidates should have 5+ years in process engineering/validation, strong GMP documentation practices, and experience with CAPAs and risk assessments.

Qualifications

• 5+ years in Process Engineering, Validation or CQV within FDA-regulated environments.
• Experience in Medical Device, Diagnostics, Biotechnology, Pharmaceuticals or similar sectors.
• Strong GMP documentation practices and writing skills.
• Experience with CAPAs, deviations and risk assessments.
• Ability to lead cross-functional teams and manage deliverables across departments.

Responsibilities

• Lead and execute manufacturing process characterization studies.
• Perform process capability assessments and data analysis.
• Support process optimization and continuous improvement initiatives.
• Lead root cause investigations and CAPA implementations.
• Coordinate IQ/OQ/PQ protocols and equipment qualification.
• Collaborate with Manufacturing, Operations, Engineering, Maintenance and QA teams.

Skills

Process validation

IQ/OQ/PQ protocols

GMP compliance

Process characterization

Root cause analysis

Technical writing

Equipment qualification

Job description

Validation & Engineering Group seeks a Senior Process Engineer CQV Validation Engineer to lead manufacturing process characterization and validation activities. The role focuses on IQ/OQ/PQ execution, equipment qualification, and continuous improvement in a primarily on-site setting with potential limited remote work based on project requirements.

Candidates should have 5+ years in process engineering/validation, strong GMP documentation practices, and experience with CAPAs and risk assessments.