ESSENTIAL FUNCTIONS
• Ensure the facilities and production equipment, such as HVAC, washing, filling, stoppering, capping and labeling equipment, lyophilization and sterilization equipment and technology are maintained in accordance with cGMPs and FDA regulations and assure efficient, uninterrupted service to the site.
• Responsible for maintaining all manufacturing equipment, plant utility systems and the physical plant including all equipment controls and electrical distribution systems.
• Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing heating, ventilating and air conditioning systems, upgrading the water for injection system and rebuilding/upgrading filling and packaging equipment and installing and start-up of new manufacturing and support equipment.
• Responsible for insuring the validated state of all equipment, systems and facilities is maintained. Also responsible for ensuring that compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations is maintained.
• Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
• Responsible for maintaining all 110. 208, 480v system within the plant.
• This job requires the highest level of commitment because job functions performed improperly could result in damage costing $500-10,000. Improperly performed work could result in a halt to production costing $1000-$100,000. Improper handling of equipment or product could result in losses over $10,000.
• Job function requires high physical demand. Lift in excess of 75lbs, ability to move or handle large motors, cabling, rigging and other activities related to equipment repair or installation. All functions may occur on a daily basis.
• Perform other duties as assigned.

EDUCATION/EXPERIENCE REQUIREMENTS
• Requires a High School Diploma or equivalent with a preferred minimum of 5 years related experience in a regulated setting, preferably in a manufacturing environment.
• Must have an Arizona Journeyman license or be capable of obtaining one.
• Must be knowledgeable in the National Electrical Code, in LOTO & PPE requirements, and Maintenance Management programs. Training will be provided for any deficiencies in the essential functions.
• Must have a working knowledge of power transfer technology including mechanics, pneumatics and hydraulics.
• Must be familiar with machine controls including Programmable Logic Controllers, relay logic, and operator interfaces, plant utility systems including high pressure steam, heating, ventilating and air conditioning, metal working including machining and welding.
• Must be able to assign work to individuals or teams that will provide the best results, and be available to support critical assignments, and be able to instill a teamwork concept.
• Must be able to mentor/encourage mentoring between different skilled trades personnel and be able to communicate/interfaces with system owners.

Qualifications
Computer/Software Skills
Requires proficiency in basic MS Word, Outlook, Excel
Compliance Knowledge
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
General Competencies
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Written Communication
Requires ability to interpret / write general business documents
Problem Solving
Requires ability to solve routine problems
Level of Supervision
Requires direct supervision
Impact of decisions
Impacts one department