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Lead Project Engineer

2 months ago

Germantown, United States Verista Full time

Lead Project Engineer Responsibilities: Managing the responsibilities on multiple simultaneous projects and/or clients. Driving the activities as client facing leader and responsible party. Act as the defined point of escalation and issue management on client projects Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of project tasks. Maintaining (and ensuring the team maintains) clear, detailed records of specifications and change control activities for potential compliance audits. Develops and delivers multi-work stream project plans with complex dependencies and numerous vendors. Is responsible for major sections of large client capacity planning, budget, and resource and materials plan. Provides individual feedback to project team members on their contributions, quality of deliverables and overall performance on the project. Development, implementation and communication of project scope, schedules, and budgets. Manage materials planning and budget development. Alert of potential budget over-spend. Organize and document project team meetings including management and accountability for action items. Develop specifications for vendor bids. Vendor interface. Minimum Requirements: Must be willing to work onsite in Germantown, WI Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution. Minimum 7 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 #J-18808-Ljbffr