C&Q Engineer

Insight Global; Morris Plains (NJ); On-site; USD 100,000 - 140,000; Full time

Job summary

Insight Global's client seeks a Validation/CQV Engineer to support commissioning, qualification, and validation activities for equipment and systems at a pharmaceutical manufacturing facility.

You will author and execute IQ/OQ/PQ protocols, risk assessments, deviation investigations, and qualification reports, while ensuring GMP compliance and collaboration with project teams.

Qualifications

• 5+ years of CQV/Validation experience in pharma/manufacturing
• Experience authoring/IQ/OQ/PQ protocols, risk assessments, and qualification reports
• Strong GMP understanding and validation lifecycle knowledge
• Experience with deviation investigations and change control processes
• Experience executing equipment or facility qualification protocols

Responsibilities

• Support commissioning and qualification activities for manufacturing equipment and systems
• Author and execute validation lifecycle documentation including IQ/OQ/PQ protocols, risk assessments, and qualification reports
• Support protocol execution, troubleshooting, and deviation investigations during qualification activities
• Collaborate with engineering, quality, validation, and project teams to ensure timely project delivery
• Attend project meetings and provide updates on validation deliverables, risks, and timelines
• Track project milestones and escalate delays, issues, risks, and technical concerns to Validation Management
• Ensure compliance with GMP regulations and site validation procedures
• Support electronic validation processes utilizing Kneat
• Execute Grade A and Grade B/C smoke studies within classified manufacturing environments

Skills

CQV experience

Validation lifecycle

GMP knowledge

IQ/OQ/PQ protocols

Risk assessments

Deviation investigations

Project collaboration

Documentation execution

Aseptic manufacturing

Equipment qualification

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

Job description

An Insight Global client is seeking a Validation/CQV Engineer to support commissioning, qualification, and validation activities for equipment and systems at a pharmaceutical manufacturing facility. This individual will be responsible for authoring and executing qualification documentation, supporting risk assessments and deviation investigations, and partnering closely with project teams to ensure successful delivery of validation milestones in a GMP-regulated environment. The ideal candidate has strong CQV experience, hands-on protocol execution experience, and expertise supporting aseptic manufacturing environments.

Day-to-Day:

• Support commissioning and qualification activities for manufacturing equipment and systems
• Author and execute validation lifecycle documentation including URS, Qualification Plans, Risk Assessments, Commissioning Protocols, IQ/OQ/PQ protocols, and Qualification Reports
• Support protocol execution, troubleshooting, and deviation investigations during qualification activities
• Collaborate with engineering, quality, validation, and project teams to ensure timely project delivery
• Attend project meetings and provide updates on validation deliverables, risks, and timelines
• Track project milestones and escalate delays, issues, risks, and technical concerns to Validation Management
• Ensure compliance with GMP regulations and site validation procedures
• Support electronic validation processes utilizing Kneat
• Execute Grade A and Grade B/C smoke studies within classified manufacturing environments

Must-Haves:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• 5+ years of CQV, Validation, or Commissioning experience within the pharmaceutical, biotech, or regulated manufacturing industry
• Experience authoring and executing validation documentation including IQ/OQ/PQ protocols, risk assessments, and qualification reports
• Strong understanding of GMP requirements and validation lifecycle principles
• Experience supporting deviation investigations and change control processes
• Experience using Kneat or similar electronic validation systems
• Experience executing equipment or facility qualification protocols

Plusses:

• Expertise performing Grade A and Grade B/C Smoke Studies
• Experience supporting aseptic manufacturing or cleanroom environments
• Experience with sterile processing, fill-finish, or biologics manufacturing facilities
• Previous experience supporting large capital projects or facility expansions
• Familiarity with Commissioning, Qualification, and Validation (CQV) best practices in pharmaceutical manufacturing