Validation Specialist

Job Description

Validation & Engineering Group, Inc. (V&EG) 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:

Alcohol System Validation Specialist (CQV – GMP Manufacturing)

We are seeking an experienced Alcohol System Validation Specialist to support the qualification and validation of alcohol storage, distribution, and delivery systems within a GMP-regulated manufacturing operation. This role plays a key part in ensuring systems used for cleaning and sanitization meet regulatory requirements and are fit for intended use.

Key Responsibilities:

• Execute IQ, OQ, and PQ for alcohol systems, including tanks, loops, pumps, and point-of-use connections

• Develop, review, and approve validation protocols, reports, and traceability documentation

• Ensure compliance with GMP, FDA, and internal quality standards

• Support risk assessments, deviations, and change controls related to validated systems

• Partner with Engineering, Quality, and Operations during system installation and modifications

• Support audits and regulatory inspections as a system SME

Qualifications:

• Bachelor’s degree in Engineering, Science, or related field

• Hands-on experience in CQV within regulated manufacturing environments

• Strong knowledge of validation lifecycle and GMP documentation practices

• Experience validating utility or process systems (alcohol systems preferred)

• Strong communication and technical writing skills

Preferred Experience:

• Pharmaceutical, biopharmaceutical, or medical device manufacturing

• Utility systems validation (alcohol loops, WFI, clean steam, compressed gases)

• Risk-based validation approaches

Full-time