Maintenance Technician s primary responsibility for maintaining the building with respect to appearance. Perform any general maintenance throughout non-controlled and controlled areas through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a pharmaceutical manufacturing facility.
Essential Duties and Responsibilities:
Production Maintenance Technician
- Under general supervision, performs breakdown and preventive maintenance of critical plant equipment on a regular basis to include, but not limited to Bioreactors, Chromatography Equipment, Process Tanks, Fill Machines, Cleaning systems, conveyers, sterilizers, and associated support equipment. May 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 may be responsible for repairing manufacturing equipment and building components; doors, wetted fire system, lighting, mechanical and electrical equipment as assigned.
- Will provide basic troubleshooting, diagnostic, and repair of 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.
- Requires basic 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 Company EH&S and Factory Mutual requirements.
- Must 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 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
- Produce maintenance reports, forms, and records.
- Reviews and provides feedback on equipment, maintenance or other related procedures.
- Provide regulatory and partner audit support.
- Interpret electrical schematics, I/O wiring and panel drawings, Utility, process system/equipment, plumbing, ductwork, and HVAC P&ID's.
- Must constructively interact with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.
- May perform general labor duties as needed and may be required to work in awkward locations.
- Will participate in On-Call rotations for after-hours facility and manufacturing support and may work outside of established shift hours upon short notice.
- May perform other duties as assigned
- Technical Skills Developing.
- Troubleshooting Developing.
- Theoretical Knowledge - Basic knowledge of maintenance systems
- Written Communication - Able to document process and successfully uses GDP.
- Interpersonal Communication - Demonstrates appropriate communication within the department and to supervisor.
- Presentation Skills Developing.
- Sphere of Influence Developing.
- Leadership Developing.
- Planning Developing.
- Processing Capabilities - Able to perform operations with oversight.
- Project Performance - Able to constructively participate in projects affecting the local department.
- Training - Proactively seeks opportunities to learn new skills.
- Continuous Improvement - Actively performs as equipment and room owner. Applies 5S and TPM as required to improve area.
The position requires shift, weekend, and holiday work. Overtime may be required at times with short notice.
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 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
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
The aforementioned requirements are preferred for internal candidates. They must demonstrate the proficiencies/qualifications in order to qualify for the position.
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: blood borne 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.
- 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
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.