Commissioning & Qualification (C&Q) Specialist / Engineer

Validation & Engineering Group; South Carolina; Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

3+ years experience

GMP/FDA/ISO knowledge

Technical writing

Cross-functional teamwork

Problem solving

Communication

Educación

Bachelor's degree in Engineering/Life Sciences

Descripción del empleo

Current job opportunities are posted here as they become available.

Commissioning & Qualification (C&Q) Specialist / Engineer

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning & Qualification (C&Q) Specialist / Engineer

We are seeking Commissioning & Qualification (C&Q) Specialists and Engineers with experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.

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.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field preferred.
• 3+ years of experience in commissioning, qualification, validation, engineering, or a 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 highly valued.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.