C&Q Engineer for GMP Systems Validation

Validation & Engineering Group, Inc.; Town of Texas (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks Commissioning & Qualification (C&Q) Specialists and Engineers with experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.

The team collaborates across Engineering, Quality, Validation, Manufacturing, Automation, and Project Management to ensure equipment, utilities, facilities, systems, and processes meet GMP and regulatory standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field preferred.
• 3+ years of experience in commissioning, qualification, validation, or related field.
• Experience in pharmaceutical, biotech, medical device, or GMP-regulated environments.
• Knowledge of IQ/OQ/PQ, FAT/SAT, risk assessments, and validation documentation.
• Strong technical writing, communication, and problem-solving skills.
• Ability to work effectively in cross-functional project teams.
• Experience with manufacturing equipment, process systems, utilities, facilities, automation, laboratory equipment, or computerized systems is valued.

Responsibilities

• Support commissioning, qualification, and validation activities for equipment, utilities, facilities, systems, and processes.
• Develop, review, and execute C&Q documentation, including URS, risk assessments, FAT/SAT, IQ/OQ/PQ, protocols, and reports.
• Support equipment/system startup, troubleshooting, testing, and turnover.
• Work closely with Engineering, Quality, Validation, Manufacturing, Automation, and Project Management teams.
• Ensure activities comply with GMP, FDA, ISO, and applicable industry standards.
• Support deviations, change controls, and other project documentation as needed.

Skills

Technical writing

Cross-functional teamwork

Problem solving

Quality systems knowledge

Education

Bachelor's degree in Engineering/Life Sciences

Tools

IQ/OQ/PQ

FAT/SAT

URS & validation docs

Job description

Validation & Engineering Group, Inc. (V&EG) seeks Commissioning & Qualification (C&Q) Specialists and Engineers with experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.

The team collaborates across Engineering, Quality, Validation, Manufacturing, Automation, and Project Management to ensure equipment, utilities, facilities, systems, and processes meet GMP and regulatory standards.