Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
The Process Engineer role requires an excellent understanding of mechanical and electrical systems in a bio pharmaceutical GMP manufacturing facility.
Key Responsibilities include but not limited to:
- Hands-on experience in troubleshooting and repairing bioprocess equipment is critical. This equipment includes fermenters, centrifuges, chromatography skids, incubators, BSCs and various laboratory equipment.
- Will work closely with facilities mechanics to minimize equipment down times, expedite PM schedules
- Will assist in maintaining preventative maintenance programs for the bioprocess equipment; this includes generating preventative maintenance SOPs/records for various equipment (manufacturing/lab), change control, and facility quarantines.
- Initiating/completing various types of GMP documentation such as change control, deviations, ICARs will be very important
- Will be a company SME on bioprocess equipment across all operating departments (PD, Manufacturing, QC).
- Will be relied upon for BAS operations for the facility.
- Works with subcontractors as needed on equipment preventative maintenance and repairs.
- Will assist as needed in other facilities groups such as metrology and the general maintenance/utilities group.
- Accurately maintains/completes all equipment logbooks and maintenance records within a software maintenance management program.
- Will aid in training of mechanics on the various pieces of bioprocess equipment throughout the facility.
- Participation in facility expansion, validation will be expected.
- Works under general supervision to meet project goals.
- Will recommend parts/supply purchases for equipment within the manufacturing/lab areas.
- Works closely with manufacturing/lab staff to troubleshoot and repair equipment problems.
- Works closely with various departments at Paragon and helps as needed.
- Must follow Paragon safety procedures, practices and the cGMPs.
Education & Experience:
- Bachelor degree in Engineering or related scientific field preferred
- 3 years work experience GMP / Bio-Pharma Maintenance &/or Engineering
- Must have proficient knowledge of controls and automation operations
- Must be able to demonstrate clear and effective communication skills
- Class III Stationary Engineer’s license is preferred
- Will be working in an FDA regulated cleanroom environment that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.)
- Must have the ability to lift/carry 40 lbs and to work on ladders/step stools.
- Requires working extended periods on his/her feet in a fast-paced environment
- Requires automation and controls engineering design, repairs and maintenance.
- Shift work and/or weekend work will be required at times.