Project Engineer

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

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 testing of automated manufacturing equipment / systems