- Support the design, installation, start-up, commissioning, qualification and maintenance of equipment, systems and utilities associated with cGMP Manufacturing, Laboratories and Warehouse.
- Demonstrate a strong understanding of HVAC, controls, mechanical, electrical and utility systems, and be able to troubleshoot as necessary.
- Understanding of thermodynamics, psychrometric properties and HVAC/mechanical design is highly desirable.
- Monitor and respond to alarms generated from the BMS/QEMS, including off-hours and weekends.
- Responsible for launching and/or supporting technical investigations, deviations, CAPAs, etc. related to GMP facilities, utilities, and equipment.
- Develop and/or enhance departmental standard operating procedures.
- Ensure through continuous improvement and routine monitoring that equipment works to design and manufacturer's specifications.
- Participate in the planning, design, budgeting, scheduling and execution of assigned projects.
- Establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.
- Independently applies advanced engineering techniques and analysis and provide technical guidance to less experienced design and engineering personnel.
- Conduct routine inspections of premises and equipment.
- Oversee work performed by maintenance and/or external contractors to ensure conformance to design and industry standards.
- Other duties as required.
- BS or MS in Mechanical Engineering field is required.
- 5 years of related BioPharma/Life Sciences experience required.
- Prior experience with Facilities operations in a cell therapy manufacturing facility, or experience with cell therapy manufacturing facility MEP design is highly desirable.
- Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
- Extensive knowledge and experience designing/operating to ASHRAE, ISO, ISPE, SMACNA, etc. is highly desirable.
- Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
- Experience using Building Management Systems (Siemens - Apogee/Desigo) and Environmental Monitoring Systems is preferred.
- Demonstrable experience with cGMP capital, maintenance, and operating projects.
- Prior experience using Reliability Centered Maintenance is highly desirable.
- Excellent oral and written communication skills required.
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Senior Plant Engineer - Philadelphia, United States - Planet Pharma
Description
This is a direct-hire (permanent/salaried) position with our Biotech client in Philadelphia, PA. It's 100% on-site, so candidates must be local or open to relocation to Philadelphia. Candidates must have solid hands-on experience with cell therapy manufacturing for consideration.
Overview
The Senior Plant Engineer is responsible for the operation and optimization of the equipment, systems and utilities of a cGMP Cell Therapy Manufacturing Facility. Collaborate with Maintenance and Metrology groups to develop programs for equipment maintenance and calibrations. Coordinate with the Facilities, Engineering, Operations and Quality teams to ensure maximum uptime and efficiency of all systems and equipment.
Primary Responsibilities
Position Requirements
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