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 instrument calibrations and operation intended to keep the facility instrumentation and 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.
Follow written calibration procedures.
Accurately complete calibration paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements.
Perform calibration of all types of plant instruments, including coordinating access to equipment working around customer’s needs.
Maintain calibration documentation that demonstrates each instrument’s NIST Traceability.
Maintain and troubleshoot facility standalone instrumentation and control systems.
Review and update calibration procedures based on field experience.
Identify opportunities for improving Calibration program.
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 instrument failures/breakdowns.
Support contractors performing tasks within building.
Ensure that contractor employees follow company safety and cGMP standards.
Oversee technical quality of work performed.
Lead Small Projects
Manage small (Perform any other tasks/duties as assigned by management.
* We all must embrace the QUALITY culture.
Qualifications and Requirements
H.S. diploma or G.E.D. is required. Associates Degree in Electronics or Military (PMEL) training preferred.
1-5 years of experience in instrumentation/calibration 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 principles and theory of pressure, temperature and weight sensing devices.
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.)
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 complex systems and instruments.
Ability to clearly describe technical issues.
Ability to clearly and neatly document work performed.
Ability to revise calibration 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.
Good knowledge of NIST applied to calibrations
Experience with the operation/use of general hand and power tools, instruments and testing apparatus common to the electronic and instrumentation fields is required.
Ability to read P&ID’s, electrical drawings, and blueprints.
Ability to work independently with minimal supervision.
Good organizational, interpersonal and communication skills (oral and written).
Comfortable working in production environment with multiple priorities.
Able to work 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
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.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 50 pounds.
##Job Category: R&D/Regulatory Affairs##
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.