Maintenance Manager, Clean Services

Description

Job Title: Maintenance Manager, Clean Services

Reports To:  VP of Engineering

FLSA Status: Non-Exempt

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Corporate Statement:

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

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Job Purpose:

This position is responsible managing the preventative maintenance activities of all cleanroom, clean utilities, and clean equipment operating in support of Nephron Pharmaceuticals manufacturing activities and for the management of the maintenance technicians supporting these activities.

Under limited supervision, oversees, coordinates, and manages the cleaning of the GMP manufacturing cleanroom areas and a variety of preventative maintenance activities on storage equipment, GMP support utilities systems, GMP support equipment, and support facility areas. Candidate must be able to follow Standard Operating Procedures (SOP’s) and company policies.

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Essential Duties and Responsibilities:

Ø Work with VP of Engineering to ensure cleaning of all GMP manufacturing cleanrooms areas by using approved disinfectants and Standard Operating Procedures (SOP’s).

Ø Work with VP of Engineering and Operations Leadership to ensure execution and completion of preventative maintenance for GMP equipment, such as sterilizers, stills, WFI, Clean Steam, Nitrogen, etc.

Ø Work with VP of Engineering and Operations Leadership on preventative maintenance activities for GMP utilities systems. These preventative maintenance activities include daily verifications of GMP utilities operational parameters, and this includes systems like a WFI System, Clean Steam Generator (CSG), Compressed Air Systems, Medical Grade Gases System, and Chilled Water System. 

Ø Work with VP of Engineering and Operations Leadership to ensure all activities are coordinated and scheduled to meet production requirements. 

Ø Ensure all work is performed in accordance with Standard Operating Procedures (SOP’s).

Ø Responsible for management of technicians providing preventative maintenance, repair, and up-keep on all clean utilities and equipment.

Ø Responsible of following cGMP documentation practices and industry guidelines for pharmaceutical manufacturing. Candidate must be able to follow Standard Operating Procedures (SOP’s). 

Ø Assist Engineering Department on the execution of engineering, renovation, and upgrade projects.

Supplemental Functions:

Ø Assists with additional work duties or responsibilities as evident or required.

Ø Performs other duties as assigned or apparent.

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Job Specifications and Qualifications:

Knowledge:

• Thorough knowledge of all maintenance disciplines (mechanical, electrical, plumbing, software automation).
• Knowledge of architectural, mechanical and electrical drawings.
• Knowledge of function and operation of WFI generation, Clean Steam production, Compressed Gas distribution, Sterilizers, Stability Ch