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)
* alcohol system validation specialist to support the qualification and validation of alcohol storage, distribution, and delivery systems within a gmp-regulated manufacturing operation.
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
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