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Senior Validation Engineer

L6

virtual vocationsDenver, COyesterday
Leading validation activities in a full-time capacity, the Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation for equipment and processes in GMP regulated environments while serving as a subject matter expert and providing guidance to junior team members.
Key Responsibilities: Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP regulated assets Oversee validation activities for internal and client tech transfer projects, including authoring and executing validation documents Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally to align validation activities with project timelines
Required Qualifications: Bachelor's degree in a life science, engineering, or related technical field 7-11 years of experience in the biotech, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP requirements and risk-based validation principles Advanced validation expertise in equipment, computerized systems, and process validation Experience supporting audits and regulatory inspections
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Level

LeadL6

Location

Denver, CO

Occupation

Validation Engineers

Industry

Custom Computer Programming Services

Posted

yesterday

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