Senior Plant Engineer

Direct Hire

Philadelphia, PA (onsite)

Salary: $130k-150k depending on experience

relo help offered

Must be a US citizen (sponsorship and C2C not available)

Must have a degree in Mechanical Engineering

Must have Cell therapy manufacturing experience

Must have at least 5 years of biopharma/life sciences industry experience

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

• 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 manufacturers 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.

Position Requirements

• 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.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must be able to work in a cleanroom lab setting with biohazards / various chemicals.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing up to 20 pounds.

by Jobble