Nature and Scope

The Maintenance Supervisor is responsible for ensuring efficient operations of processing equipment through effective planning of equipment changeovers, repair, preventative maintenance and upgrades. Supports manufacturing operations (equipment preparation and wash, batching, sterile/non-sterile filling and inspection and packaging) by ensuring equipment set-ups are completed appropriately (aseptically as required) and in a timely manner. Reviews the operation of equipment and lines constantly, to minimize unplanned downtime, anticipate and solve problems in a timely manner, and to identify opportunities for improvement. Day to day responsibilities will include directing the staff of mechanics, setting priorities for projects and work orders and enforcing safety and housekeeping practices, while following cGMP guidelines.

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.

Initiate, implement, and manage process equipment maintenance program based on industry best practices, with an emphasis on planning/scheduling and preventive/predictive maintenance.
Coordinate and direct projects and process mechanics, making detailed plans to accomplish goals and directing the integration of technical activities.
Assure equipment are ready for daily and weekly start up, with a strong focus on problem areas.
Coordinate Maintenance Mechanics to adjust daily schedules as needed to support operations.
Ensure PM task are completed in a timely manner and are coordinated with manufacturing.
Act as liaison to management to ensure department goals are met.
Assist to coordinate shutdown activities and scheduling of PM task and repair work
Provide overall supervision of the Process Maintenance Mechanics, including prioritization and evaluation of work, recommendation and approval of personnel actions, and assessment of team and individual competencies as well as training. Develop, implement, and measure plans to address gaps.
Responsible for hiring of process mechanics.
Prepare report, analyze data, and provide recommendations for improving equipment operations and solving maintenance-related problems.
Track, analyze and improve key parameters such as asset utilization, maintenance cost, PM compliance, schedule compliance, etc. for manufacturing equipment.
Provide overall management for manufacturing equipment parts inventory, balancing the requirement to have appropriate spare parts on hand while maintaining reasonable internal inventory costs.
Initiate and carry out projects that improve efficiency and/or reduce operating costs.
Communicate and coordinate manufacturing equipment maintenance efforts with Engineering group and others as necessary.
Assist with managing the use of external contractors.
Participate in the development and review of equipment SOPs.
Assure that all pertinent SOPs are being followed, maintains compliance with cGMPs. Confer with and assist personnel under their supervision regarding manufacturing difficulties.
Assure proper training of all personnel under their supervision, and participates in cost-estimating activities.
Meet regularly with mechanics; communicates company information. Develop goals and action plans, reviews progress/performance.
Maintain and update operating and training manuals for the mechanics.
Responsible for communication coordination among various shifts.
Provide leadership in creating and maintaining a safe workplace.
Actively involved in deviations, CAPAs and change controls from performing investigations to executing change control work.
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 lead a project and provide direction
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.

High School degree required and Bachelor’s Degree (BA or BS) preferred.
Minimum of 1 year in a leadership role, required
A minimum of 5-7 years of relevant Mechanic experience and previous experience in the pharmaceutical industry required. Previous supervisory experience required.
Able to follow instructions and document activities as outlined in SOPs (Standard Operation Procedures)
Able to effectively communicate
Basic Microsoft Office and Windows skills.
Well versed in safety programs (e.g. Lock out / Tag out, line breaking) Advanced skills including: electrical, welding, machinery troubleshooting, and mechanical equipment.

Physical Environment and Requirements

Intermittently sitting, standing, walking, or stooping.
May be required to stand; walk; stoop; bend; kneel; and climb steps.
May require use of hands and use of arms. Lifting requirements up to 50lbs.
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.

Expected Salary Range:

$91,000 - $105,000

The salary range, displayed is the minimum and maximum annual salary 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

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