CQV Engineer

GxP Associates; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Job summary

GxP Associates in the United States is seeking an experienced Process Engineer to support GMP manufacturing operations in a cGMP‑regulated pharmaceutical/biotech facility. The role focuses on technical support for manufacturing processes, equipment, process improvements, troubleshooting, and qualification activities for clinical and commercial production.

The candidate will work with Manufacturing, Engineering, Quality, CQV, Facilities, and external vendors to ensure processes remain robust,

Qualifications

• 2–5 years of process engineering experience in regulated pharma environments.
• Bachelor degree in Chemical/biochemical engineering or related field.
• Hands-on GMP experience with manufacturing processes and equipment.

Responsibilities

• Provide day-to-day technical and engineering support to GMP manufacturing operations.
• Support development, implementation, and optimization of manufacturing processes and equipment.
• Assist with qualification activities (IQ/OQ/PQ) and validations.
• Collaborate with QA, CQV, Facilities, and external vendors to ensure compliant operations.
• Analyze process data to identify improvements and optimize efficiency.

Skills

cGMP knowledge

Process engineering

Root cause investigations

Change controls

IQ/OQ/PQ

FMEA

CAPA

Technical writing

Documentation

Data analysis

Education

Bachelor's degree in Chemical Engineering or related

Tools

TrackWise

Maximo

CMMS

Job description

We are seeking an experienced Process Engineer to support manufacturing operations within a cGMP-regulated pharmaceutical/biotechnology facility in Raritan, NJ. The Process Engineer will provide technical support for manufacturing processes, equipment, process improvements, troubleshooting, and qualification activities supporting both clinical and commercial production.

The ideal candidate will have 2–5 years of hands‑on process engineering experience within pharmaceutical, biotech, biologics, cell therapy, or other highly regulated manufacturing environments. Experience working with GMP manufacturing equipment, process optimization, root cause investigations, change controls, and cross‑functional technical projects is highly preferred.

This role will work closely with Manufacturing, Engineering, Quality, CQV, Facilities, and external vendors to ensure manufacturing processes remain robust, compliant, efficient, and inspection‑ready.

Key Responsibilities

• Provide day‑to‑day technical and engineering support to GMP manufacturing operations.
• Support the development, implementation, optimization, and troubleshooting of manufacturing processes and equipment.
• Evaluate process performance and identify opportunities for process improvement, efficiency, reliability, and capacity enhancement.
• Support commissioning, qualification, and validation activities for manufacturing equipment and process systems.
• Develop and review technical documentation, including process specifications, engineering assessments, protocols, reports, and operating procedures.
• Participate in equipment and process troubleshooting, root cause investigations, and corrective action implementation.
• Support deviations, CAPAs, change controls, and other quality‑system activities associated with manufacturing processes.
• Perform or support risk assessments, FMEAs, and process impact assessments.
• Collaborate with CQV and Quality teams to ensure equipment and processes meet GMP and validation requirements.
• Support equipment FAT/SAT, commissioning, IQ/OQ/PQ, and process readiness activities as required.
• Analyze manufacturing data and process trends to identify recurring issues and improvement opportunities.
• Partner with Manufacturing and Operations teams during process start‑up, scale‑up, technology transfer, and production readiness activities.
• Coordinate with equipment suppliers and contractors on technical issues, modifications, and implementation activities.Support continuous improvement initiatives using structured problem‑solving and engineering principles.
• Ensure engineering and process documentation is maintained in an inspection‑ready state.
• Participate in cross‑functional project teams supporting clinical and commercial manufacturing operations.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biotechnology, Biochemical Engineering, or a related technical discipline.

Experience

• 2–5 years of process engineering experience in pharmaceutical, biotechnology, biologics, cell therapy, medical device, or another GMP‑regulated manufacturing environment.
• Hands‑on experience supporting GMP manufacturing processes and production equipment.
• Experience with process troubleshooting, root cause analysis, and continuous improvement.
• Experience supporting equipment qualification, validation, or commissioning activities.
• Experience working within a regulated quality system and following established GMP procedures.

Required Skills & Knowledge

• Strong understanding of cGMP manufacturing principles and regulated production environments.
• Experience with manufacturing process development, optimization, and troubleshooting.
• Working knowledge of IQ/OQ/PQ, commissioning, validation, and equipment qualification.
• Experience supporting deviations, CAPAs, investigations, and change controls.
• Familiarity with risk assessments, FMEA, and process impact assessments.
• Strong technical writing and documentation skills.
• Ability to interpret engineering documentation, equipment specifications, process data, and technical drawings.
• Strong analytical and problem‑solving capabilities.
• Ability to work effectively with Manufacturing, Quality, Engineering, CQV, Facilities, and external vendors.
• Strong communication and organizational skills with the ability to manage multiple priorities.

Preferred Qualifications

• Experience in cell therapy, CAR‑T, biologics, aseptic processing, or sterile manufacturing.
• Experience supporting both clinical and commercial manufacturing operations.
• Experience with process equipment such as bioreactors, mixers, tanks, skids, centrifuges, filtration systems, autoclaves, freezers, or other GMP production equipment.
• Experience with technology transfer, process scale‑up, process characterization, or manufacturing readiness.
• Familiarity with TrackWise, Maximo, CMMS, or electronic quality/document management systems.
• Knowledge of 21 CFR Parts 210, 211, and 1271.
• Experience working with data integrity and ALCOA+ principles.
• Experience supporting inspection readiness and regulatory audits.
• Process troubleshooting and technical problem solving
• GMP manufacturing support
• Process optimization and continuous improvement