Pharmaceutical Facilities and Maintenance Tech

The Facilities and Maintenance Technician will be responsible for maintenance and repair of all equipment and facilities for McGuff Companies, corporate wide, working with minimal supervision. The MT will coordinate and execute all facilities and equipment operational readiness including, but not limited to, all maintenance and repairs (facilities, buildings and equipment), execute the preventive maintenance system, equipment specifications development, assist and coordinating the spare parts, equipment storage and tools inventory. Responsibilities also include maintenance and troubleshooting of cGMP production equipment in both preventive and condition based, reactive modes. Responsibilities will also include troubleshooting and solving production process problems with processes or equipment already in operation. The MT will also be a technical Subject Matter Expert (SME) with input to Engineering. Must be able to effectively communicate and work closely with many different departments within the organization.

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Summary of Description/Primary Responsibilities:

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1. Hands on in facility, cGMP manufacturing, and infrastructure maintenance.

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2. Maintain functional capabilities for all equipment and facilities for McGuff Pharmaceuticals and McGuff Compounding.

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3. Coordinate, implement, and participate in preventative and reactive maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.

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4. Develop and implement facility safety and good house-keeping. Including training of employees on occupation hazards and corresponding safety precautions necessary for the safe performance of assigned duties including, such as, lock out tag out procedures. Such as and specifically, ensure the respirator program is properly designed and implemented for McGuff.

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5. Make appropriate facility and equipment adjustments or modifications within company and GMP guidelines and notify Quality Systems of any abnormal parameters.

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6. Lead and organize specialized maintenance and equipment projects. Troubleshooting and repairing all manufacturing and facilities support equipment.

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7. Monitor and maintain all HVAC systems verifying they are running properly and efficiently to ensure proper climate control while keeping energy costs to a minimum.

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8. Complete and maintain all necessary documentation including applicable cGMP documents.

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9. Read and understand electrical, pneumatic, hydraulic, mechanical, and other diagrams and troubleshooting electrical controls, electrical motors and servomotors.

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10. Be the Subject Matter Expert (SME) for equipment and facilities and work with Production and Quality Systems staff to troubleshoot, correct and prevent non-conforming products, process, materials, etc… (through MRB board actions) as necessary.

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11. Other varied duties as assigned.

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II. Physical Requirements:

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· The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require lifting/carrying up to 50 pounds.

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· Must be able to see, hear, speak and write clearly in order to communicate others.

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III. Qualifications include:

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· Education: High school diploma or equivalent. Preference to include; Technical Institution certification or Journeyman certification/licensing and/or advanced degree in related field or comparable additional experience.

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· Minimum of 5 years relevant hands on industry experience in a fast paced manufacturing or packaging environment. Prefer experience with sterile injectable drugs and aseptic processing.

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· Strong experience with mechanical and electrical disciplines.

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· Strong background in machine maintenance and troubleshooting skills. Knowledge and experience working with machine control systems including PLCs, servo controls, and Variable Speed Drives. Strong ability with troubleshooting the controller and I/O devices associated with the controller

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· Strong ability to install, repair, and maintain all components of manufacturing & packaging equipment in a safe and timely manner.

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· Ability to effectively read and understand mechanical & electrical drawings, including floor plans.

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· Able to work independently, in teams, and with in-direct staff (as assigned).

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· Knowledge and understanding of cGMP's. The preferred candidate will have experience in pharmaceutical, medical device or biologic production, engineering, quality assurance, and technical report writing.

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· Computer literate and familiar with Microsoft Excel as well as computerized database systems.

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IV. Expectations:

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· Comply with all McGuff Policies and Procedures.

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· Appropriate professional demeanor.

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· Knowledge, understanding and compliance of the dress code.

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· Ability to work with others.

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· Adequate communication skills.

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· Work with all McGuff employees to foster and promote quality system controls and procedures.

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· Must be capable of working independently without direct supervision to complete tasks/assignments

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· Excellent customer skills.

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