Pharma Validation Engineer - IQ/OQ/PQ & GMP Expert

Commissioning Partners LLC.; New Jersey; On-site; USD 80,000 - 120,000; Full time

Job summary

Commissioning Partners LLC. seeks a Validation Engineer to support commissioning, qualification and validation activities for pharma/biotech facilities and systems in New Jersey.

The role involves developing and executing IQ/OQ/PQ protocols, reviewing URS/FRS, and ensuring data integrity and regulatory compliance. The candidate will coordinate with Engineering, Manufacturing, QA, and external vendors, maintain validation documentation, and support audits and inspections as needed.

Qualifications

• 3+ years of experience in pharmaceutical/biotech regulated environments.
• Experience with qualification protocols and GMP documentation.
• Familiarity with cGMP, FDA regulations, and data-integrity principles.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ and equipment qualification activities.
• Support commissioning and qualification of manufacturing equipment and facility systems.
• Prepare URS/FRS/Design Specifications and risk assessments.
• Execute testing, document results, and resolve protocol exceptions.
• Review P&IDs, drawings, manuals, and vendor docs; coordinate with cross-functional teams.
• Ensure activities comply with GMP, FDA, and SOPs.

Skills

IQ/OQ/PQ

GMP documentation

CAPA

Change control

Risk assessment

Engineering drawings

Technical writing

Communication

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related field

Tools

Validation management systems

Job description

Commissioning Partners LLC. seeks a Validation Engineer to support commissioning, qualification and validation activities for pharma/biotech facilities and systems in New Jersey.

The role involves developing and executing IQ/OQ/PQ protocols, reviewing URS/FRS, and ensuring data integrity and regulatory compliance. The candidate will coordinate with Engineering, Manufacturing, QA, and external vendors, maintain validation documentation, and support audits and inspections as needed.