Equipment Validation Engineer (Pharma)

Job Description Responsibilities: For the oversite of the sites Validation program ensuring equipment and systems remain in a qualified, operational state of compliance associated with cGMP manufacturing. Leads continuous quality system improvements for the validation program. Write and execute Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents. Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities. Assist in investigating deviations related to facilities, utilities, and equipment. Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines. Write and revise Standard Operating Procedures (SOPs). Identify gaps in existing program and devise approaches to improve them. Ability to work in a fast-paced, dynamic, and innovative environment. Work with limited supervision and take ownership of projects to achieve schedule, financial and technical goals. Maintain accurate and thorough records. Other duties may be assigned as required. Requirements: BS in Engineering (chemical or mechanical) with 5+ years of related field/experience or AS in Engineering (chemical or mechanical) with 10+ years of related field/experience or Non-degreed with 15+ years of related field/experience. Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, and pharmaceuticals. Understanding of commissioning / qualification / validation principles. Experience authoring and executing Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents. Experience working in a cGMP environment. Excellent interpersonal and communication skills (verbal and written) are required. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Experience with investigating deviations related to facilities, utilities, equipment, and systems. Experience working with multi-functional department teams to meet timeframe for project implementations. Experience writing SOPs. Ability to lead continuous quality system improvements for the validation program.

Created: 2025-09-06