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Validation Engineer

Company: Experis
Location: Kalamazoo
Posted on: April 10, 2021

Job Description:

Validation Engineer opening in the Kalamazoo area. Great opportunity to work for a Pharmaceutical company in the Kalamazoo area and be a part of history!ROLE SUMMARY:This job description applies to the capital project to create a new aseptic facility at the site in Kalamazoo, MI. ROLE RESPONSIBILITIES* Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams (See Role Summary.) Commissioning and Verification (aka Qualification) will follow the ASTM E2500 standard.* Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstream. This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.* Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.* Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.* Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.* Collaborate with matrix organization to optimize Change Control implementation and management.* Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.* Assist C&V Lead with the preparation of C&V status reports: include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.QUALIFICATIONS: * Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.* Minimum 4 years technical experience.* Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.Essential Skills:* Communication Skills: Excellent oral and written communication skills, including presentations.* Ability to write clearly, concisely, and persuasively in a professional environment.

Keywords: Experis, Kalamazoo , Validation Engineer, Engineering , Kalamazoo, Michigan

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