Hybrid C&Q Specialist/Engineer for Pharma & Biotech

Pinnaql, Inc.; Texas; Hybrid; USD 110,000 - 140,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking Commissioning & Qualification (C&Q) Specialists and Engineers for future opportunities.

The team works across pharmaceutical, biotech, and medical device environments, supporting commissioning, qualification, and validation activities for equipment, facilities, and processes. The role emphasizes collaboration with Engineering, Quality, and Manufacturing to ensure GMP and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 3+ years of experience in commissioning, qualification, validation, engineering, or related field.
• Experience in GMP-regulated environments such as pharmaceutical, biotech, or medical device.
• Familiarity with IQ/OQ/PQ, FAT/SAT, risk assessments, 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.
• Support deviations, change controls, and other project documentation as needed.

Skills

Technical writing

Communication

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Validation & Engineering Group, Inc. is seeking Commissioning & Qualification (C&Q) Specialists and Engineers for future opportunities.

The team works across pharmaceutical, biotech, and medical device environments, supporting commissioning, qualification, and validation activities for equipment, facilities, and processes. The role emphasizes collaboration with Engineering, Quality, and Manufacturing to ensure GMP and regulatory compliance.