Pharma & Biotech Commissioning & Qualification Engineer

Veg Group; South Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Commissioning & Qualification (C&Q) Specialist/Engineer in a life sciences setting. This role focuses on supporting commissioning, qualification, and validation activities for equipment, facilities, and processes.

The candidate will develop IQ/OQ/PQ and related documentation, work across engineering, quality, and manufacturing teams, and ensure adherence to GMP, FDA, and ISO standards. A strong writing and problem-solving skillset is required.

Qualifications

• 3+ years of experience in commissioning, qualification, validation, engineering, or related field.
• Knowledge of GMP, FDA, ISO standards and validation documentation.
• Strong technical writing, communication and problem-solving skills.

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.

Skills

3+ years experience

GMP/FDA/ISO knowledge

Technical writing

Cross-functional teamwork

Problem solving

Communication

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Validation & Engineering Group, Inc. is seeking a Commissioning & Qualification (C&Q) Specialist/Engineer in a life sciences setting. This role focuses on supporting commissioning, qualification, and validation activities for equipment, facilities, and processes.

The candidate will develop IQ/OQ/PQ and related documentation, work across engineering, quality, and manufacturing teams, and ensure adherence to GMP, FDA, and ISO standards. A strong writing and problem-solving skillset is required.