C&Q Engineer: Pharma Validation Specialist

Veg Group; Kentucky; On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Commissioning & Qualification (C&Q) Specialist/Engineer with experience in pharmaceutical, biotech, medical device, or GMP-regulated environments.

You will support commissioning, qualification, and validation activities for equipment, utilities, facilities, systems, and processes, and develop IQ/OQ/PQ protocols and related documentation. Collaborate with Engineering, Quality, Validation, Manufacturing, Automation, and Project Management teams to

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in commissioning, qualification, validation, engineering, or related field.
• Experience in GMP-regulated environments (pharma, biotech, medical device).
• 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.

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

Communication

Cross-functional teamwork

Problem-solving

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Validation & Engineering Group, Inc. is seeking a Commissioning & Qualification (C&Q) Specialist/Engineer with experience in pharmaceutical, biotech, medical device, or GMP-regulated environments.

You will support commissioning, qualification, and validation activities for equipment, utilities, facilities, systems, and processes, and develop IQ/OQ/PQ protocols and related documentation. Collaborate with Engineering, Quality, Validation, Manufacturing, Automation, and Project Management teams to