Job Description

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.

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.

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 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.

DocuSign Envelope ID: 2132BCE6-A4A6-42D5-96B1-F01EF38B076B2

 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.

 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 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.

 9TMust 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.

 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

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.