Maintenance Mechanic

3 days ago

Thousand Oaks, California, United States BioSpace, Inc. Full time
About the Role:

As a Maintenance Mechanic at Takeda, you will be responsible for performing general maintenance throughout non-controlled and controlled areas, adhering to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) in a pharmaceutical manufacturing facility. You will report to the Maintenance Supervisor and work closely with the team to ensure the smooth operation of equipment and facilities.

Key Responsibilities:

  • Perform breakdown and preventive maintenance of critical plant equipment, including bioreactors, chromatography equipment, process tanks, fill machines, cleaning systems, conveyers, sterilizers, and associated support equipment.
  • Provide secondary support to the operation and maintenance of manual and automated door systems, pumps, and equipment, industrial control systems, as responsibility assigned to Facilities Manufacturing Maintenance in both cGMP and non-cGMP areas.
  • Support and repair manufacturing equipment and building components, including doors, wetted fire systems, lighting, mechanical, and electrical equipment, as assigned.
  • Provide basic troubleshooting, diagnostic, and repair of equipment and equipment components related to positional responsibilities, including pumps, piping, and plumbing components, vacuum pumps, sanitary piping, blowers, and facility equipment.
  • Demonstrate basic familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes, including NFPA, NEC, UBC, UMC, and UPC, in compliance with Company EH&S and Factory Mutual requirements.
  • Be familiar with plant and divisional SOPs as related to positional and department responsibilities.
  • Must follow safety rules and ensure compliance with CA state and federal EPA regulations and laws, including CAL OSHA and OSHA.
  • Ensure personal Training Plan execution and compliance, attend required training, meetings, and Tiers.
  • Work with and oversee contractor/vendor work.
  • Produce maintenance reports, forms, and records.
  • Review and provide feedback on equipment, maintenance, or other related procedures.
  • Provide regulatory and partner audit support.
  • Support planning and scheduling activities.
  • Interpret electrical schematics, I/O wiring, and panel drawings, utility, process system/equipment, plumbing, ductwork, and HVAC P&ID's.
  • Constructively work with peers and clients in manufacturing, maintenance, utility plants, analytical labs, and contracted services.
  • Participate in On-Call rotations for after-hours facility and manufacturing support and may work outside of established shift hours upon short notice.
  • Demonstrate understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP), and Good Documentation (GDP).
  • Basic knowledge of maintenance systems would be ideal.


What You Bring to Takeda:

  • High school diploma or equivalent and some experience in Biotech maintenance or Manufacturing would be ideal. Schooling should include intermediate mathematics (algebra and geometry).
  • Have a broad mechanical trade knowledge and skills like that obtained in a formal four-year registered apprenticeship program.


Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • The overall physical exertion of this position requires medium to heavy work.
  • May be required to kneel, bend/twist at the neck/waist, reach above/below the shoulder, squat, fine manipulation, repetitive use of right and left hands/arms, and climb (use step stools and ladders) up to 1 hour.
  • May be required to power grasp, sit, push/pull, and office work activities with hands/arms between 1-2 hours.
  • May require simple grasping and be required to walk between 3-4 hours.
  • May be required to stand over 4 hours.
  • May be required to lift up to 75lbs. Lifts per shift are up to 20 times.
  • May be required to carry up to 50lbs. Carry distance of up to 200ft. Carries per shift are up to 20 times.
  • May be required to gown frequently and balance when gowning into clean areas.
  • May be required to work around moving equipment and machinery.
  • May be required to walk on uneven ground or slippery surfaces.
  • May be exposed to noise above 85 dBA. This may require hearing protection and other protective equipment to be worn.
  • May work and have exposure to hot, cold, wet environment/conditions.
  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
  • May be required to work at heights above floor level.
  • Not required to operate foot controls or repetitive foot movement.
  • May require the use of special visual or auditory protective equipment.
  • May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste. Will be exposed to equipment that handles plasma-based products.
  • May be required to drive to travel to other facilities, training sites, and off-site meetings.
  • May be required to work in confined areas.
  • May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
  • Will need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
  • May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
  • May be exposed to sunlight, heat, dust, gases, and fumes. Possible exposure to cool/hot storage conditions.
  • May climb up and into large processing tanks for cleaning or inspection.
  • May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
  • Will work around chemicals such as paint, flooring materials, refrigerants, alcohol, acids, buffers that may require respiratory protection.
  • Able to work 4 days per week/7 to 10 hour days. Training schedule for the first 6 months - 1 year will require 5 days per week/8-hour day.
  • May be required to work or be assigned to a different shift as needed.
  • This position requires overtime, weekend, and holiday work.
  • May be required to participate in an on-call program.

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