Under limited supervision, identify, plan, and direct the maintenance, preventive maintenance of the production manufacturing equipment to up keep of LA Pant site manufacturing and production equipment up and running within the validated states. Incumbent will be responsible for, but not limited to: Calibrate, Maintain, troubleshoot and perform repairs on the Process Instrumentation and manufacturing equipment systems. Prepare calibration reports and details document completed work orders. Understand the Advance process and control theory of a Critical or Major system.
Overhaul and perform corrective and preventive maintenance on plant equipment, filtration systems, centripetal equipment, pumps, sterilization, high speed filling and packaging equipment and electrical controls and instrumentations to include, but not limited to, Pressure/Level/Temperature/pH indicators and transmitters, electrical distribution, variable frequency drives, electric motors and electrical control systems.
Additional responsibilities may include manufacturing supports systems and equipment and office building equipment /systems (i.e. monitor the building management system "BMS"). Essential Duties and Responsibilities
- Expected to demonstrate the skills and knowledge as a Calibration and as a Mechanical Technician.
- Performs preventive maintenance of critical plant equipment on a regular basis, to include, but not limited to, Manufacturing, Packaging, Sterilization Equipment and electrical control systems as responsibility assigned to Manufacturing Maintenance in both cGMP and non-cGMP areas.
- Responsible for repairing and or replacement of the mechanical, electrical and controls components of Manufacturing, Sterilization and Packaging Equipment as assigned.
- Requires familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes to include NFPA, NEC, UBC, UMC, and UPC in compliance with L. A. City, Shire EH&S and Factory Mutual requirements.
- Must follow safety rules and ensure compliance with L.A. City, CA state and federal EPA regulations and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulation agencies to include but not limited to L.A. City Building and Safety, SCAQMDM, L.A. City Bureau of Sanitation, and CAL OSHA.
- Individual will be responsible for a multi-craft duties within the business unit.
- Ability to verify mechanical and electrical drawings for accuracy. Perform SOP job plans and drawing redlines as necessary.
- Ability to troubleshoot, diagnose, and repair of critical equipment including but not limited to: plant equipment, filtration systems, centripetal equipment, pumps, sterilization, high speed filling and packaging equipment and electrical controls to include, but not limited to, indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems.
- Ability to assist Reliability Engineering Group in equipment failure root cause analysis with prompt resolution.
- Requires familiarity with generally accepted building and electrical codes to include NEC and UMC in compliance with LA City and Shire EH&S.
- Support engineering projects including but not limited to: equipment installation, commissioning, and validation process.
- Cross-train new employees and teammates.
- Follow and comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies.
- Ensures personal and staff's Training Plan execution and compliance.
- Attend required training and meetings.
- Performing Disposal of Hazardous Waste
Education and/or experience
- Must have a strong knowledge of instrumentation calibration and mechanical systems, such as controllers, indicators, control valves, PLC, analyzers, sensors, pumps, etc.
- Must have a strong knowledge of manufacturing equipment including distribution, filtration systems, centrifuges, sterilization, autoclaves, process tanks, incubators and CIP/COP systems, PLC based process control systems, Human Machine Interface (HMI) configuration.
- Knowledge of basic chemical and biological safety procedures.
- May perform removal of hazardous waste.
- Must have the ability to correctly complete high school-level mathematics.
- Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Ability to read, write and interpret technical documents and instructions, electrical and mechanical drawings, equipment blue prints and piping and instrumentation drawings (P&ID).
- Must have customer service and leadership attitude to take ownership of any maintenance related problem.
- Excellent communication and leadership skills.
- A self-starter with the ability to work independently and use good judgment. Must be able to handle multiple priorities. Must be proactive, results orientated, and have a strong attention to detail.
- Must be able to work overtime on a short notice and support standby program.
- High school diploma or equivalent required. 8 years of Process Instrumentation and Calibration experience in a pharmaceutical manufacturing environment
- 5-7 years of with a Certified Calibration Program by American Society for Quality
- Must be able to lift, push, pull and carry up to 50 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must able to climb ladders and move about in closed quarters facility non-manufacturing support areas.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment and climb up and into large processing tanks.
- Will be working in a loud area that requires hearing protection and other protective equipment to be worn.
- Will work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
- Must be required to work or be assigned to a different shift as needed.
- Must be able to work overtime as required.
- Inside and outside working conditions.
- Must be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- Must be required to drive company vehicle.
- If this position is assigned to any of the weekend shift, it will be required to work on the company holidays.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.