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Engineer
2 weeks ago
Description/Comment: ONSITE - SHIFT - MON - FRI - 9AM - 5:30PM - DURATION - 3 MONTHS.
The Engineer is responsible for supporting the readiness and reliability strategy for the cell therapy facility at Princeton, NJ site. The Engineer is responsible for contributing to the success of Facilities, Process Equipment and Utility automated and control systems. This position supports the Facilities and Engineering team by providing technical work product. Reports to the Director of Facilities and Engineering.
Responsibilities:
Comprehensive understanding of Good Manufacturing Practices guidelines outlined in Code of Federal Regulations.
Technical knowledge to write, prepare and execute the Change Controls, Investigations, and SOPs.
Responsible for completing assigned work scopes of a project including documentation, compliance commitments, simulation, testing, and commissioning / qualification support.
Daily responsibilities include SOP development/drafting, implementing performing equipment data back ups/archiving, creating/training end user and assigning access levels and controls for GMP utilities and process equipment.
Supports CMMS (Blue Mountain RAM) data migration; asset master data creation and induction, determining and establishing events, measurement data templates, and workflows; standardizing equipment list and hierarchy; supporting validation activities
Developing and maintaining site SOPs for the CMMS
Performs monthly PMs and troubleshooting automation related issues.
PC hardware and software maintenance for Laboratory and production equipment.
Technical writing of automation lifecycle documents (Functional Specification, Design Specification, Testing Plans).
Understanding of process automation needs (e.g. batch reports, Building Temp and RH Trending, Audit Trail reports) for pharma manufacturing.
This person will be called upon to provide support on projects and engineering maintenance activities.
Resourceful and well organized.
Performs other duties as required.
Experience and Education Requirements
BS in technical field (Electrical, Mechanical, Industrial Engineering), or Associates Degree in a technical field coupled with relevant engineering experience
Minimum 2 years experience in Biotech, Pharmaceutical or Specialty Chemical Industries.
May be required to be On Call to support a 24/7 manufacturing operation
Knowledge of industry guidance:
Physical Requirements
Regular office environment with exposure to moderate noise.
Must be able to independently work in/navigate around construction sites, to include working at heights of up to 6 feet, climbing ladders, and lifting objects up to 50 pounds (5% of duties or less).
Must be able to independently work in/navigate around Biotech, Pharmaceutical facilities, and wearing PPE.
bility to sit for extended periods of time, ability to input data into computer utilizing hands and fingers to tab to different fields to input data.
Job Type: Full-time
Schedule:
8 hour shift, 9AM-6PM, weekends as needed. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 142 104 Campus Drive 13-3523163 Princeton NJ 08540 United States Education: dditional Job Details:
