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Associate Project Engineer

4 months ago

Kalamazoo, United States Verista Full time

Associate Project Engineer Responsibilities: Draft and execute Verification Testing protocols. 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. 1-3 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 testing of automated manufacturing equipment / systems (e.g., PLC-controlled). Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms Ability to work as part of a team Strong problem-solving and critical thinking skills Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes) Basic skills with EXCEL and PowerPoint Strong interpersonal skills and clear communication capabilities Experience with and tolerance for high levels of challenge and change Experience in GMP regulated environment Proven attention to detail and organization in project work Capable of working on assigned tasks without mentorship

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