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 Chambers, Isolators, and Clean Room Ventilation systems.
• Knowledge of clean room construction and Class / ISO rating.
• Specific expertise, skills and knowledge within facility maintenance gained through education      and experience.

Skills:

• Leadership, creating positive work environment.
• Strong project management skills with ability to execute on short- and long-term deliverables.
• Supervision and evaluation of department personnel
• Effective negotiating skills with demonstrable ability to influence without direct authority.
• Written and verbal communication via in-person, phone, and email contact.
• Operating computer and relevant software,
• Proficient in MSWord, Excel, Outlook, Teams, and PowerPoint.

Abilities:

• Demonstrated ability to perform detail-oriented work.
• Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.
• Ability to identify improvements to facilities, utilities and their associated procedures.
• Ability to handle contending priorities and managing partner expectations.
• Ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Ability to incorporate industry knowledge to appropriately evaluate and resolve complex issues within a fast paced and changing      business environment.
• The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• Ability to objectively coach employees and management through complex, difficult, and emotional issues.
• Ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and      provides participation, learning, feedback and recognition.
• Ability to work in a fast-paced manufacturing setting and handle multiple projects

Education/Experience:

• Regionally accredited Bachelor’s degree in a Technical Discipline and/or equivalent pertinent experience.
• A minimum of five (5) years’ experience with utility and equipment maintenance in a GMP Pharmaceutical/Biotech environment is preferred.
• A minimum of two (2) years’ people management.
• Experience with WFI, Clean Steam, Compressed Gas, and Clean Room Ventilation systems.
• Aseptic Manufacturing experience preferred.

Licensing and Certifications:

• None required.

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Working Conditions / Physical Requirements:

• Position requires bending (overhead to floor), climbing (floor to platform), lifting (up to 70lbs), reaching (overhead to      floor), vision (20/20), standing (60%), and walking (40%).
• Incumbents are required to wear safety glasses, personal protective equipment, and other non-specified protective      equipment as necessary.

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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. 

Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.