Scope : The Project Engineer provides project engineering for the Melville site with an emphasis on capital projects. Refrigeration experience a plus.
Main Responsibilities
- Conceptualizes projects and develops execution strategies to meet the business objectives. Develops options with cost benefits analysis to assist site leadership to identify the appropriate project scope and budget.
- Assures that projects comply with related environment, health & safety, and cGMP regulations. Maintain compliance with state and federal codes.
- Provides technical Engineering and Capital Project management expertise for the design, and implementation of manufacturing processes, instrumentation, and equipment
- Capital management expertise includes managing the whole project lifecycle Project Scope, User Requirements, Conceptual Design, Detailed Design, Installation, Commissioning, Validation, Operations Handover)
- Build effective and collaborative relations with all functional areas in the plant.
- Perform design studies, engineering test plans, troubleshooting, submitting Change Control Requests, and coordinating efforts with QA, Regulatory, Safety, Production, Validation, and Maintenance.
- Provides conceptual design and estimates, including construction, commissioning, and start-up of equipment to execute the project.
- Maintains current knowledge of developments related to manufacturing and applies that knowledge to company goals.
- Makes independent decisions within defined area of responsibility.
- Collaborate very close with all other Site Organizations, to ensure legal compliance of technical solution adopted for projects execution.
- Manages cost throughout detailed cost report
- Manages schedule throughout proper scheduling tools like project
- Prepares Monthly status reports for his projects which include milestones reporting, risks reporting, cost reporting
Background and Experience :
A minimum of 3 years of experience in a biopharmaceutical, or food, or OTC consumer industry in a role as project engineering.
Certified Facility Manager (CFM) and / or Project Management Professional Certification (PMP) a plus.
- Bachelors Degree in Engineering.
- Deep knowledge of Microsoft Office, AutoCAD, Microsoft Project
- Knowledge of FDA cGMPs, Federal, State and Local Environmental regulations, standard operating procedures, QA / QC documentation, equipment validation, equipment specifications, factory acceptance testing, site acceptance testing, equipment start-up and commissioning.
Knowledge, Skills, and Abilities
- Strong communication and organizational skills
- Demonstrated ability to effectively prioritize and coordinate functions and activities
- Excellent project management skills and comfortable with project management tools.
- Problem solving skills, results oriented.
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