American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Nature and Scope
A technical position involving equipment repairs and maintenance activities intended to keep the facility equipment (i.e. process, utility, and general equipment) within compliance of cGMPs.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
A. Perform Preventative Maintenance Tasks
Follow written PM procedures.
Accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health and safety requirements.
Perform PM of all types of plant equipment including coordinating access to equipment working around customer’s needs.
B. Execute Repairs
Respond to customer requests and/or alarm conditions.
Assess instrument failures/breakdowns, systematically identify problems, and restore to operation.
Accurately document repair activities.
Support Quality Assurance investigations of failures/breakdowns.
C. Operate Plant Utilities
Monitor site (steam, electric, chilled water, compressed air, etc) and clean (WFI, clean steam, etc) utility operating parameters.
Respond to out of range conditions or trends.
Troubleshoot issues that arise.
D. Contractor Support
Support contractors performing tasks within building.
Ensure that contractor employees follow company safety and cGMP standards.
Oversee technical quality of work performed.
E. Lead Small Projects
Manage small (<$10K) projects to completion.
Perform any other tasks/duties as assigned by management.
Qualifications and Requirements
- H.S. diploma or GED required. Trade School/certification in a technical discipline preferred.
- Minimum 1 year of experience in maintenance in a manufacturing or lab environment preferred.
- Experience working in a Pharmaceutical or similar regulated industry preferred.
- Must be comfortable in the use of Microsoft Office Applications, including Microsoft Word, and Excel.
- Basic knowledge of CMMS (computerized maintenance management) systems.
- Basic knowledge of electrical systems and electronics.
- Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
- Basic understanding of engineering principles as they apply to facility and production equipment.
- Basic knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.).
- Some background in troubleshooting mechanical and electrical control problems with Allen Bradley or Siemens PLC experience.
- Details oriented.
- Hands-on ability to isolate problems and identify root cause of issues.
- Ability to focus on problem at hand in systematic manner.
- Able to troubleshoot systems and instruments.
- Ability to clearly describe technical issues.
- Ability to clearly and neatly document work performed.
- Ability to follow PM procedures that clearly define required tasks.
- Working knowledge of OSHA safe work practices.
- Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
- Ability to read P&ID’s, electrical drawings, and blueprints.
- Ability to work independently with some supervision.
- Good organizational, interpersonal and communication skills (oral and written).
- Comfortable working in production environment with multiple priorities.
- Able to work and interconnect effectively as a team member.
- Able to juggle multiple tasks with supervisory guidance.
- Comfortable working in culture of performance that emphasizes responsiveness.
- Works to ensure that customer timelines are understood and met.
- Flexibility to work multiple shifts and off hours during shutdown plus some overtime.
- This position is part of a multi-shift operation and may require assignment to a regular off shift and/or weekends schedule.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Ability to work overtime as needed.
Physical Environment and Physical Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Employee must be able to occasionally lift and/or move up to 50 pounds.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.