California, United States of America
Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes.
Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
Collaborate with department teams to complete specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
Provide general labor services throughout all areas maintained by the Maintenance department.
Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
Provide general expertise and training to junior staff.
Assist as technical SME with identification, purchase, and organization of spare parts.
Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
Cleaning and organization of designated work areas in Manufacturing and Utilities.
Complete GMP and other controlled documentation.
Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
Education and Experience
High school graduate.
7 years general maintenance experience and minimum 3 years in a cGMP environment.
EPA Section 608 Technician Certification, a plus.
Knowledge, Skills, and Abilities
Good communication skills, both written and oral.
Prompt, consistent and orderly work habits.
Ability to read and interpret P&ID drawings
Overall knowledge of mechanical, pneumatic, hydraulic, refrigeration, steam, electrical systems, controls, and maintenance methods. Specializing in at least one
General troubleshooting skills
Ability to work independently on all but complex or controversial issues.
Ability to interact well with others in a team environment.
Strong organizational skills and time management skills.
Ability to learn and use Microsoft based platforms and/or company Intranet and e-mail.
Ability to use computer software applications (MS Word/Excel).
Ability to use Building Automation System (BAS) and Manufacturing Control Systems
Available to work overtime when necessary and work varying shifts, including an On-Call program.
General knowledge of shop tool operation and safety.
Work Environment/Physical Demands/Safety Considerations
Schedule may include shift work (12 hour shifts), one weekend day, evening or night hours, or full off-shift hours.
Expected to be on feet for 8 to 10 hours a day.
Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
Climb heights up to 30 feet by ladder.
Lift up to 50lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make-up or jewelry can be worn when working in the clean room environment.
Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
Work with electrical systems 480VAC and below
Work with hazardous materials and chemicals.
Work on pressurized gasses and liquids
Work on cryogenic systems
Work on steam systems
Wear air purifying respirator and wear necessary hearing protection.
Crawl, kneel and stoop and work in small work spaces.
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