| Hiring For C & V Project Engineer, Onsite in MI at Remote, Remote, USA |
| Email: [email protected] |
| Title:- C & V Project Engineer Kalamazoo MI-onsite 8/19/24-3/15/25 All visa workable Project Engineer Responsibilities: Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams. 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. Lead and participate in development and execution of complete verification documentation in accordance with Pfizer Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream. Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment. Provide or arrange for development of complete verification documentation in accordance with Pfizer Quality Standards and cGMP requirements for assigned work stream. 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. Must be willing to work onsite in Kalamazoo, MI Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution. Requirements Minimum 4 years technical experience. Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements. Communication Skills: Excellent oral and written communication skills, including presentations. Ability to write clearly, concisely, and persuasively in a professional environment. Demonstrated ability to interact effectively with all levels of the organization. Demonstrated understanding of risk-based approach to commissioning & qualification. Experience with Thanks & Regards Manish Kumar Sr. Technical Recruiter Email: [email protected] Linkedin: linkedin.com/in/manish-chaudhary-jaat-21b9011a3 ANVETA, Inc Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA -- Keywords: cprogramm information technology Michigan Texas Hiring For C & V Project Engineer, Onsite in MI [email protected] |
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| Mon Jul 08 20:30:00 UTC 2024 |