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.

Perform Calibrations
Follow written calibration procedures.
Accurately complete calibration paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and 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.
Provide leadership and technical direction to fellow technicians on technical details.
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 instrument failures/breakdowns.
Contractor Support
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
Identify improvement projects, develop scope and estimates, and manage small (<$10K) projects to completion.
Perform required calibrations on instrumentation and equipment per schedule and SOPs.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

H.S. diploma or G.E.D. is required. Associate degree in Electronics or Military (PMEL) training preferred.

5-10 years of experience in instrumentation/calibration in a manufacturing or lab environment required.
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.
Good knowledge of CMMS (computerized maintenance management) systems.
Good knowledge of principles and theory of pressure, temperature, and weight sensing devices.
Good knowledge of electrical systems and electronics.
Good understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
Good understanding of engineering principles as they apply to facility and production equipment.
Good knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.).
Detail 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 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.
Ability to proofread other’s work for accuracy.
Working knowledge of OSHA safe work practices.
Good 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 or as a team leader.
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 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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