Validation Engineer
1 Ph3
Description
The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution. Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary.
Requirements
B.S. in science/engineering field and 1 to 2 years of equipment qualification/validation experience. Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs). Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines. Hands-on experience with Kaye validator and temperature mapping. Soft skills such as technical writing, good communication skills, root-cause investigation and cross-functional coordination skills, detail-oriented mindset.
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R&D and ValidationBaltimore & Elkridge, MD
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CEL-SCI
BIOTECHNOLOGY
Biologics
LocationVA - Vienna
Open Jobs4
Validation Engineer
CEL-SCI
This listing was originally posted on CEL-SCI's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.