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Project Engineer
Ref No.: 19-08776
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Project Engineer in Swiftwater, PA with one of our top client.
 
Job Title: Project Engineer
Job Id: 19-08776
Location: Swiftwater, PA 18370
Duration: 3 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • BS in chemical or mechanical engineering, or related degree supplemented with relevant experience.
  • Experience in pharmaceutical/biopharmaceutical industry. Experience in cGMP environment, including commissioning, qualification and validation.
  • Well-develop.
  • Experience in cGMP environment, including commissioning, qualification and validation.
  • Well-developed communication skills, both verbal and written.
  • Based on level, should have demonstrated experience managing teams consisting of internal staff, supervising engineering and construction activities, and preparing turnover documentation from C execution and as-built drawings.
  • Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Larger projects may require earned value/progress tracking systems.
  • Leadership skills. Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.)
  • The Equipment Engineer executes process design engineering activities for site capital and operational improvement projects within the Technical Engineering team in Swiftwater with a primary focus in the aseptic fill/finish area.
  • In support of capital projects, the Equipment Engineer will participate in the development of concepts and specifications, design and fabrication, commissioning and qualification of process equipment systems in a GMP environment.
  • The Equipment Engineer will also support licensed GMP operations by providing technical leadership for investigations/assessments, and by developing and implementing improvement projects.
  • This Equipment Engineer will lead or participate in the development of URS's, equipment, instrument, and component specifications, engineering calculations, computational fluid dynamics simulations, engineering design including PFD and P&ID development, FAT and SAT planning/execution, initial start-up, commissioning and qualification of process systems.
  • The Equipment Engineer will also be a hands-on, process and equipment oriented, technical leader for the aseptic filling area.
  • This includes providing engineering support for the operation, control, and maintenance of all aseptic fill/finish equipment including: vial washers, dehydrogenation tunnels, aseptic fillers, lyophilizes, capping equipment, tray loaders, denester/renesters, visual inspection equipment, autoclaves, RABS and Isolators.
  • The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments. 
Responsibilities
  • Develop technically sound concepts and scope for aseptic fill/finish capital and improvement projects
  • Specify and design equipment
  • Manage equipment vendors to meet requirements as well as project cost and schedule
  • Develop and execute C&Q deliverables
  • Identify changes to improve processes and address root causes identified in investigations in a cGMP environment.
  • Develop and implement improvements through cross-functional interactions.
  • Interface with Industrial Operations to ensure the manufacturing process equipment operates in its validated state and consistently meets the production schedule. Continuous improvement is required.
  • Provide Subject Matter Expert (SME) knowledge as required on equipment within area of responsibility.
  • Closely interact with Industrial Operations to develop, implement, and improve operations and maintenance practices and procedures.
  • Education: Bachelors 
Skills and Experience
  • Aseptic
  • Budget
  • CGMP
  • Cost Reporting
  • Design Engineering 
Additional Skills
  • Process Design
  • Process Systems
  • Project Engineer
  • Scheduling
  • SME
  • Subject Matter Expert
  • Technical Engineering
  • Technical Leadership
  • Visual Inspection
  • Word
  • Biopharmaceutical
  • Body Engineering
  • Computational Fluid Dynamics
  • Engineering Design
  • Fluid Dynamics
  • Lubrication
  • Manufacturing Process
  • Mechanical Engineering
  • Microsoft Excel
  • Microsoft PowerPoint
  • Microsoft Word
  • Production Schedule
  • Simulations
  • Engineer
  • Engineering Support
  • Equipment Engineer
  • Estimating
  • Excel
  • Fabrication
  • GMP
  • Leadership Skills
  • Maintenance
  • Microsoft Office
  • Operations
  • PowerPoint 
Contact
Sunny Rajput
Direct: (732) 272 0302 | Email: Sunny.R@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com