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.
Review and update PM procedures based on field experience.
Identify opportunities for improving PM program.
Provide leadership and technical direction to fellow technicians on technical details.

B. Perform Calibration Tasks, as requested.

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.
Complete calibration tasks assigned by management.
Identify opportunities for improving Calibration program.

C. 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.

D. Operate Plant Utilities

Monitor site (steam, electric, compressed air, nitrogen etc.) and clean (purified water, clean steam, etc.) utility operating parameters.
Respond to out-of-range conditions or trends.
Troubleshoot issues that arise.

E. Contractor Support

Support contractors performing tasks within building.
Ensure that contractor employees follow company safety and cGMP standards.
Oversee technical quality of work performed.

F. Lead Small Projects

Identify improvement projects, develop scope and estimates, and manage medium (<$25K) 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.
6 years of experience in maintenance 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.
Advanced knowledge of electrical systems and electronics.
Advanced understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
Advanced understanding of engineering principles as they apply to facility and production equipment.
Advanced knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.).
Strong 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 complex systems and instruments.
Ability to clearly describe technical issues.
Ability to clearly and neatly document work performed.
Ability to revise PM procedures that clearly define required tasks.
Ability to proofread other’s work for accuracy.
Good knowledge of OSHA safe work practices.
Good understanding of cGMP, GDP, and FDA requirements as they apply to maintenance.
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.

Expected Salary Range (Hourly Rate):

$33.20-$41.00

The hourly rate displayed is the minimum and maximum hourly range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

· Our recruiting process includes multiple in person and/or video interviews and assessments.

· If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.

· We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

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