Project Engineer II
Posted on: May 27, 2023
Project manager and technical lead on projects including but not limited to infrastructure, manufacturing, and packaging equipment within a cGMP pharmaceutical manufacturing facility. Accountable for managing small to large capital investment projects, providing leadership during concept/design stage and execution at highest level of efficiency, quality, and employee safety.
Scope of the Role
Responsible in development, implementation, execution, and follow up of multiyear capital projects on time and on budget using the necessary local or global company methodology and tools.
Leads in project planning, tracking, spending, scope management, design, implementation strategy, execution, and follow up while ensuring quality & safety compliance within a cGMP pharmaceutical manufacturing facility during all phases of the project.
Design phase (e.g., design Failure Mode Effects Analysis (FMEA), User Requirement Specification (URS) & RFP (Request for Proposal) development),
Planning phase (e.g., Create Budget and Schedule, Vendor Management)
Implementation phase (e.g., Factory Acceptance Test (FAT), Site Acceptance Test (SAT)), Installation)
Start-up (e.g., Commissioning, Qualification and Verification (CQV) planning, Vertical Start-up (VSU) assessments)
After Action Reviews (AAR) and successful handover to site engineers.
In charge of leading site level cross-functional team (operations, process, maintenance, scheduling) for successful project execution.
Controls cost, cash flow phasing, and execution schedule of the projects.
Proactively monitors progress and issues progress reports; resolves issues and initiates appropriate corrective action to ensure critical milestones are met.
Coordinates clear communications to all key stakeholders, reporting and oversight of interdependencies and risks, to ensure the realization of the projected benefits.
Ensures project documentation is organized and accessible.
Participates and accountable for determining and developing approach to solving complex problems affecting job function, and ensuring proper resolution
University Degree in Engineering required, Chemical Engineering & Mechanical Engineering preferred
Experience with capital and budget management.
Minimum of 3-4 years' work experience with in-depth knowledge of a packaging/manufacturing facility preferred.
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Keywords: Actalent, New Rochelle , Project Engineer II, Engineering , Bronx, New York
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