Summary: The Equipment Engineer III, under the supervision of the Associate Director, Facility Engineering, will be responsible for life cycle development of new process and utility equipment for both critical upstream and downstream processes, as well as clean utility equipment in an advanced Bio-Technology facility. This engineering position will work with process development engineers, research scientists and clients in identification of equipment through development of the URS, for prototype, analytical and full scale production, for purchase and installation. The position will assist in identification of equipment of the proper type, size, materials, throughput, physical dimensions and required utilities.
The Equipment Engineer will support P&ID development; software and hardware requirements, streamline processes and participate in FATs and SATs for expeditious commissioning of equipment for the process. The Equipment Engineer III will also work with vendors and OEM through the functional design phase and traceability matrix confirmation of the equipment proposals and procurement. This position will support the various aspects of equipment procurement through initial engineering, maintenance and follow on support as well as validation and qualification. The job requires some degree of knowledge and experience with procurement and support for biotechnology equipment including fermenters, bioreactors, centrifuges, ultra-filtration skids, Chromatography skids, as well as support equipment such as incubators, ultra-low temp freezers and clean utilities.
This position requires intimate knowledge of the biotechnology processes, typical operations and the equipment used in such processes. This position may also be called upon to support utility systems (pneumatics, plumbing, electrical, chilled water), bio-waste treatment system, Quality Control (QC) laboratory critical equipment and building automation and environmental monitoring systems. Activities may also involve working with Validation, Operations and Quality Control personnel to troubleshoot and identify issues with equipment or processes.
Responsible for taking a lead role in developing equipment URS with the users, establishing selection criteria and providing capital project summaries for project management for pharma and bio-tech systems listed above, for both upstream and downstream operations, utility systems, and bio-waste systems. This includes corrective actions as well as process improvements.
Provides support for other utility and MCR support systems, including environmental control equipment, monitoring systems, and analytical laboratory equipment. Experience and knowledge to provide support for central CIP/SIP systems
Able to work with operators and technicians as well as research scientists and equipment vendors and engineers.
Mentor other engineers and technicians in GMP requirements for biotech manufacturing facilities, understand GAMP requirements, familiarity with ISPE Life Cycle requirements, understand basics of equipment procurement, capitalization, amortization and taxable nature of equipment procurement
Required Skills & Abilities:
Strong written, verbal and interpersonal communications skills. Must be able to write capital requests and proposals for new equipment, as well as operational procedures and maintenance procedures for technical equipment.
Must be able to use project management software such as Microsoft Project. Proficient with MS Office products (Word, Excel, Outlook, PowerPoint).
Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
Ability to work quickly and effectively without constant supervision.
Strong analytical and problem solving skills and experience applying these skills to resolve technical problems on complex bio-technology equipment. Should have experience on a variety of process equipment used in the bio-technology fields, preferably in viral and vaccine development.
Experience in process improvements and CAPAs in a Bio-Pharma facility.
Experience with computerized instrumentation, micro-processor controlled operations, and micro measurement equipment.
All other duties as assigned.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Experience prolonged sitting, standing, walking, bending, stooping and stretching.
Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
The ability to regularly lift and/or move up to 50 pounds.
Climb ladders and stairs of various heights.
Be exposed to wet or humid conditions.
This position may be On-Call for maintenance issues in rotation with other technicians.
Be exposed to outdoor weather conditions.
Be exposed to noisy environments.
Attendance is Mandatory
May supervise up to four (4) technicians on the technical aspects of the job.
Bachelor’s Degree preferably in Engineering such as Electrical, Chemical or Biomedical with three (3) years of experience in engineering and maintenance in an FDA regulated research or manufacturing facility; OR
Associate’s Degree preferably in Engineering such as Electrical, Chemical or Biomedical with seven (7) years of experience in engineering and maintenance in an FDA regulated research or manufacturing facility.
This position requires two (2) years’ experience in GMP equipment either in specification, procurement, installation or commissioning.
Engineering experience must include process improvements and problem solving through engineering improvements, displaying strong understanding of engineering fundamentals such as thermodynamics, chemistry or biology and physics.
Maintenance or operational experience required in bio-pharm, with emphasis on cellular growth (Upstream) and cellular harvesting equipment (Downstream), with experience in other GMP equipment to include clean utilities, such as pure water systems, clean steam generation, and CDA.