Posted to MedZilla on 9/18/2019


Takeda Pharmaceuticals

US-CA, Sr Utilities Technician SR0039119-MZ


 
 

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Every vial has a name is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing, hands on Sr. Utilities Technician. The position requires shift, weekend, and holiday work. Overtime may be required at times with short notice.

Under direct to minimal supervision, the Sr. Utilities Technician will be a craftsperson responsible for performing basic installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas. The technician will be responsible for completing various quality system and safety documentation. All work must be completed in a safe (in accordance to HRA, JHA, etc), timely manner according to planning and predefined schedules with minimal impact to production while complying with GMP, SOP, CFR and company regulations.

Sr. Utilities Technician:

Complete daily operational log sheets and general inspections on all Plant utility equipment to ensure all equipment s/systems are operating properly.

Perform assigned Preventative Maintenance work and necessary repairs of facility Utility Plan: Plant/Clean Steam, Water Systems, Water Systems (WFI,

RO, Waste and City), Air Compressors, cooling Towers and Chilled Water /Glycol refrigeration equipment.

Continuous monitoring and documentation of environmental conditions in utilities and HVAC areas via a Computer Monitoring System (SCADA, BAS), alarm investigation/response and generation /completion of applicable room reports and Attachments.

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 Takeda EH&S and Factory Mutual requirements.

Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as CAL OSHA and OSHA.

Ensures personal Training Plan execution and compliance. Attends required training, meetings, and QWTs. Interact with and oversee contractor/vendor work

Will provide troubleshooting, diagnostic, and repair equipment and equipment components related to positional responsibilities which includes but not limited to: pumps, piping, and plumbing components, vacuum pumps, sanitary piping, blowers, and facility equipment.

Qualifications

  • Technical Skills Comfortable with set-up and operations, daily maintenance, and break down of simple/routine equipment. Qualified to perform CIP, SIP autoclave, small parts preparation. Able to identify processing gaps and assist with implementation of new technologies
  • Has access to JDE and understand how to create facility Work Orders
  • Troubleshooting Proficient at troubleshooting minor to moderate problems. Understands when and to whom to elevate.
  • Theoretical Knowledge - Understands the scientific and technical background associated with areas they are performing.
  • Written Communication - Able to draft simple to moderate DCRs and complete minor NCR investigations.
  • Interpersonal Communication - Communicates professionally within and outside of the department.
  • Presentation Skills Able to present clear-cut concepts to local group.
  • Sphere of Influence Able to influence within the operational group.
  • Leadership Able to lead group through a major process step.
  • Planning Consistently understands and provides feedback for operations occurring within the current work week.
  • Processing Capabilities - Understands systems for purchasing routine items. Able to procure items and supplies.
  • Project Performance - Takes the lead during processing steps. Prepares the shift for upcoming processes.
  • Training - Can successfully train newer team members on routine processes.
  • Continuous Improvement - Actively performs as equipment and room owner. Applies 5S and TPM as required to improve area.

    Additional Qualifications

    Employee maybe required managing 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.

    Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).

    Support planning and scheduling activities as directed.

    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 Takeda EH&S and Factory Mutual requirements.

    Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as CAL OSHA and OSHA.

    Ensures personal Training Plan execution and compliance. Attends required training, meetings, and QWTs. Interact with and oversee contractor/vendor work

    Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.

    Understand ergonomic relationship between people, equipment and working environment.

    Communication with customers, and daily communication and interaction with Supervisor regarding all daily activities.

    Adhere to all SOP s during execution of daily work tasks.

    May be required to participate on call rotations for facilities/manufacturing/utilities support.

    Provides support for regulatory, partner and internal audits.

    May be responsible for development, revision and review of maintenance reports forms, records and/or procedures.

    Maybe provide training for staff as needed.

    Employee 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.

    Education and/or experience

    High school diploma or equivalent and a minimum of 3-6 years experience in Biotech maintenance or Manufacturing. Schooling should include intermediate mathematics (algebra and geometry). Should have a broad mechanical trade knowledge and skill set similar to that obtained in a formal four-year registered apprenticeship program

    Physical Demands

    The overall physical exertion of this position requires medium to heavy work.

  • May be required to sit between 1-2 hours.
  • May be required to walk between 3-4 hours.
  • May be required to stand over 4 hours.
  • May be required to bend at the neck/waist up to 1 hour.
  • May be required to squat up to 1 hour.
  • May be required to climb (use step stools and ladders) up to 1 hour. May climb up and into large processing tanks for cleaning or inspection.
  • May be required to reach above/below the shoulder up to 1 hour.
  • May be required to kneel up to 1 hour.
  • May be required to twist at the neck/waist up to 1 hour.
  • 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.
  • Requires repetitive use of both right and left hands and arms up to 1 hour.
  • May require simple grasping between 3-4 hours.
  • May require power grasping between 1-2 hours.
  • May require fine manipulation up to 1 hour.
  • May require pushing/pulling with hands/arms between 1-2 hours.
  • May require office work activities with hands/arms between 1-2 hours.
  • May be required to gown frequently and balance when gowning into clean areas.
  • May be required to drive cars, trucks, forklifts or other equipment.
  • 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.

    Working Environment

    Must be able to work more than 8 hours a day or 40 hours a workweek as required.

    Must be able to work in controlled or clean room 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 these work environments.

    The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

    May work in a cold, wet environment.

    May be exposed to sunlight and heat.

    May be exposed to dust, gases, and fumes.

    Possible exposure to cool/hot storage conditions.

    May be around moving equipment and machinery.

    May climb up and into large processing tanks for cleaning or inspection.

    May be working in a loud area that requires hearing protection and other protective equipment to be worn.

    May be required to work in a confined area as defined by the Environmental, Health, & Safety office.

    Inside working conditions.

    Will work in a cold, wet environment and hot humid environments both inside and outside of facility.

    Will work around chemicals such as paint, flooring materials, refrigerants, alcohol, acids, buffers that may require respiratory protection.

    May be required to work or be assigned to a different shift as needed.

    May be required to travel for business reasons, e.g. training or FAT

    Will have interaction with other people.

    May be required to work 4 days a week 10 hour days.

    Pace may be fast and job completion demands may be high.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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