Facilities & Maintenance Engineer McGuff Pharmaceuticals Inc - 3.3 Santa Ana, CA Job Details Full-time $85,000 - $125,000 a year 1 hour ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Opportunities for advancement Life insurance Qualifications Manufacturing plant facilities maintenance experience Interpersonal skills Customer service Industrial equipment troubleshooting Manufacturing facility experience Bachelor's degree Mechanical troubleshooting Full Job Description The Facilities and Maintenance Engineer (FME) will be responsible for maintenance and repair of equipment, utilities, and facilities for McGuff sites, working with minimal supervision. The FME will be responsible for maintaining equipment, utilities, and facilities in a state of operational readiness for cGMP-compliant manufacturing operations, including, but not limited to, managing the preventive maintenance system, troubleshooting and corrective maintenance or repairs, defining and revising equipment & facilities specifications, commissioning new or modified equipment and facilities, and serving as the subject matter expert (SME) for facilities and utilities systems.

Essential Functions and Duties:

Hands on leadership in facility, cGMP manufacturing, and infrastructure maintenance. Manage and maintain functional capabilities for all equipment and facilities for McGuff Pharmaceuticals Coordinate, implement, and participate in preventative and reactive maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary. Develop and implement facility safety. 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. Make appropriate facility and equipment adjustments or modifications within company and GMP guidelines and notify Quality Systems of any abnormal parameters. Lead and organize specialized maintenance and equipment projects. Troubleshooting and repairing all manufacturing and facilities support equipment. Managing the appropriate components, equipment storage and facilities to affect and repair equipment which will result in limited production down time and unnecessary crisis management. Monitor and maintain all HVAC, Boilers, WFI , and CA systems verifying they are running properly and efficiently to ensure proper climate control while keeping energy costs to a minimum. Complete and maintain all necessary documentation including applicable cGMP documents. Read and understand electrical, pneumatic, hydraulic, mechanical, and other diagrams and troubleshooting electrical controls, electrical motors and servomotors. Qualification of process equipment and facilities, as assigned. Qualification and validation of manufacturing processes, as assigned. 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. Other varied duties as assigned.

Physical Requirements:

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

Qualifications include:

Education:

B.S or equivalent. Preference to include; Technical Institution certification or Journeyman certification/licensing and/or advanced degree (e.g. Bachelor of Science) in related field or comparable additional experience. Minimum of 5-7 years relevant hands on industry experience in a fast paced manufacturing or packaging environment. Prefer experience with sterile injectable drugs and aseptic processing. Strong experience with mechanical and electrical disciplines. 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 Strong ability to install, repair, and maintain all components of manufacturing & packaging equipment in a safe and timely manner. Ability to effectively read and understand mechanical & electrical drawings, including floor plans. Able to work independently, in teams, and with in-direct staff (as assigned). Good oral and written communication skills, excellent interpersonal skills, and be well organized. Capable of managing maintenance systems across departments. 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. Computer literate and familiar with Microsoft Excel as well as computerized database systems.

Expectations:

Comply with all McGuff Policies and Procedures. Problem solving Appropriate professional demeanor. Knowledge, understanding and compliance of the dress code. Ability to work with others. Adequate communication skills. Work with all McGuff employees to foster and promote quality system controls and procedures. Must be capable of working independently without direct supervision to complete tasks/assignments Excellent customer skills.

Pay:

$85,000.00 - $125,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Life insurance Opportunities for advancement Paid time off Vision insurance

Work Location:

In person