C&Q Specialist — GMP-Regulated Systems Engineer

Veg Group

Town of Texas (WI)

On-site

USD 90,000 - 120,000

Full time

3 days ago

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Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Commissioning & Qualification (C&Q) Specialist/Engineer to join a leading life sciences services team in the pharmaceutical, biotech and medical device sectors.

The role focuses on supporting C&Q activities for equipment, utilities, facilities and processes, developing IQ/OQ/PQ, FAT/SAT, validation protocols and reports, and ensuring GMP, FDA and ISO compliance while collaborating with engineering, quality

Qualifications

Bachelor's degree in Engineering, Life Sciences, or related field.
3+ years experience in commissioning, qualification, validation, or related field.
Experience in pharmaceutical, biotech, medical device, or GMP environments.
Knowledge of IQ/OQ/PQ, FAT/SAT, risk assessments, and validation documentation.
Strong writing, communication, and problem-solving skills.
Ability to work effectively in cross-functional project teams.

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.