Jonathan K.
Validation Engineer at Emergent BioSolutions
- Role
- Validation Engineer at Emergent BioSolutions
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Jonathan K.
Validation Engineer with almost 5 years of experience in pharmaceutical equipment qualification generation and execution (IQ, OQ, PQ, PPQ), start-up validation and remediation.(5 years biotech) Equipment Validated: autoclaves, depyrogenation ovens, laboratory equipment, temperature controlled chambers, bulk mixing tanks, SIP/CIP systems, filling equipment. Also experienced in the use of the Kaye Validator / Data loggers, aseptic processing techniques, environmental monitoring, cleanroom gowning procedures, equipment calibration/maintenance and quality assurance documentation review and procedures. Possess exceptional attention to detail, communication skills, a strong foundational technical background and familiarity with pharmaceutical documentation procedures, cGMPs and industry guidelines.
Experience
Validation Engineer
Dec 2021 — Present · MD, US
Plan and perform annual revalidations including but not limited to isolators, a sterilizer, and a lyophilizer. • Provide Validation support for a Quality Control expansion with new laboratory instruments. • Author, review and approve validation documents throughout an equipment\'s lifecycle.
Education
University of Wisconsin-Madison
Professional Development , Construction Management
Lehigh University
Bachelor of Science, Mechanical Engineering
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