- 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.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.