Job Description

Validation & Engineering Group (V&EG), a Pinnaql Company, is seeking an experienced CQV Engineer to support a biotechnology manufacturing expansion project in Raritan, NJ.

The selected candidate will support commissioning, qualification, and validation activities associated with aseptic processing isolators, facility and utility modifications, environmental monitoring systems, and related GMP manufacturing equipment. Responsibilities will include protocol development, field execution, troubleshooting, report generation, and coordination with multidisciplinary project teams in a regulated biotechnology manufacturing environment.

Responsibilities

• Develop and execute commissioning and qualification protocols, including IQ, OQ, and PQ activities.
• Support qualification of aseptic processing isolators and associated GMP manufacturing systems.
• Support facility, utility, equipment, and cleanroom qualification activities.
• Participate in field testing, walkdowns, startup support, and troubleshooting activities.
• Support environmental monitoring qualification activities, including static, dynamic, and related studies.
• Support Air Visualization Studies (AVS) and smoke study execution activities.
• Review vendor documentation, turnover packages, engineering documentation, and test results.
• Generate qualification reports and support deviation resolution activities.
• Coordinate activities with Engineering, Manufacturing, Quality, Validation, and EHS personnel.
• Support change controls, investigations, and project documentation as required.
• Support electronic validation systems and document management workflows, including Kneat.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 5 years of CQV experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated industries.
• Experience developing and executing IQ, OQ, and PQ protocols.
• Experience supporting facility, utility, equipment, and cleanroom qualification activities.
• Strong written and verbal communication skills.
• Experience supporting qualification of aseptic processing isolators.

Preferred Qualifications (any combination of the following):

• Experience with VHP decontamination cycle development and/or qualification.
• Experience with aseptic manufacturing systems, barrier systems, isolators, or RABS.
• Experience with Environmental Monitoring Performance Qualification (EMPQ).
• Experience with Air Visualization Studies (AVS) and smoke studies.
• Experience supporting biotechnology, sterile manufacturing, cell therapy, or gene therapy facilities.
• Experience with Kneat.
• Experience working in active manufacturing environments.
• Familiarity with EHS requirements and field safety practices.

Project Information

• On-site support required in Raritan, NJ.
• Candidates with isolator and VHP experience are highly desirable.