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Validation Engineer/Specialist

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Bachelor's degree in Engineering or a related scientific field. A minimum of 5 to 10 years of experience in the medical device, biotechnology, or pharmaceutical industry (experience with liquid dosage is a plus). Proven experience in validating autoclaves is required. Familiarity with the validation lifecycle, including process, packaging, and cleaning. In-depth knowledge of regulations, including Good Manufacturing Practices (GMP). Experience in developing and implementing efficient processes to meet production demands. Exceptional technical writing and verbal communication skills. Detail-oriented with the ability to identify milestones effectively. Strong interpersonal skills to facilitate interactions across various teams and with clients. Proficiency in MS Office Suite (Word, Excel, PowerPoint) is required. Willingness to work extended hours and holidays as needed. Must be available for travel and flexible with work hours if necessary.

About the job

The Validation Engineer/Specialist will oversee all validation activities associated with the assigned project, which includes the validation of multiple autoclaves and temperature controllers. The validation scope comprises the entire validation lifecycle, execution of processes, technical documentation, gap analysis, risk assessment, and commissioning & qualification (C&Q) activities, among others.

About Validation Engineering Group USA

Validation Engineering Group USA (V&EG) is a premier service provider delivering innovative solutions to the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries. Our expertise spans Laboratory, Compliance, Computer Engineering, Project Management, Validation, and various other services.

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