Posted to MedZilla on 11/11/2019


Takeda Pharmaceuticals

US-CA, Critical Systems Supervisor SR0042420-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 Critical Systems Supervisor.

The selected candidate will supervise the operation and maintenance of all plant utilities systems, clean utilities systems and Waste Water Treatment system for the Thousand Oaks site. Applies a solid understanding of theories/practices around plant and clean utilities systems utilized by other disciplines outside the primary area of expertise toward the effective operations and maintenance of the equipment and technicians. Plans, executes and functionally directs important operational and or maintenance assignments, which require independent judgment. Assure cGMPs, SOPs, Division Procedures and Good Engineering Practices are appropriately followed in all maintenance activities. The incumbent has the responsibility and accountability to keep the facility and equipment in the assigned area operating in effective and compliant manner. Responsible for operating the systems in compliance with Air Emissions permit, Waste Water Permit and other environmental programs permits. Maintain the area and clean utilities systems inspection ready. Lead continuous improvement and cost reduction initiatives to support company operations excellence programs.

Essential Duties

Lead, Manage, Administer and Monitor the Operations and Maintenance personnel including the Technicians assigned to the Utilities and Critical Systems area to assure efficient and compliant operation and maintenance of al I systems.

Oversee and Manage Site Utilities and Critical Systems equipment failure investigations to ensure timely resolution of any issues thus assuring a continuous supply of utilities and state of compliance with all applicable standards, methods, procedures, licenses and regulations.

Identify, Lead, Influence, Drive and Support improvements that result in stable, reliable, and efficient operations.

Search, Study, Identify and Understand all cost drivers for Utilities and Critical Systems Operations and Maintenance to reduce cost of operation year over year.

In coodination with the Engineering teams, Oversee and Manage Site Utilities and Critical Systems Projects that enhance reliability for all Utilities and Critical Systems.

Track, Monitor, Assess and Report operating and performance data that give insight and indication of the stability and robustness of equipment and systems on an ongoing and forward-looking basis.

Complete, Administer and Manage all documentation to support change control and design work.

Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.). Coordinate training Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date.

Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.

Coordinate, oversee and manage contractors as needed to meet the responsibilities of the department.

Maintain equipment in sound condition, report deficiencies and record in JDE.

Responsible for the compliance with environmental permits such as Waste Water, Air Emissions, Storm Water Pollution Prevention, Spill Prevention Control and Countermeasures Plan, and others.

Qualifications

Knowledge of cGMP manufacturing.

Basic supervisory and leadership skills. Proven successful interpersonal and customer skills required.

Must be well versed in engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer, static and dynamics, engineering materials). Must possess knowledge of related disciplines.

Knowledge of basic chemical and biological safety procedures.

Able to manage multiple priorities in manufacturing plant setting

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, write, and converse in English.

Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

Good computer skills, knowledge of Microsoft Word and Excel.

Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

Knowledge of clean room management.

Employee maybe 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.

Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.

Must have the ability to navigate electronic mail systems and intranet for communication purposes.

Advanced word processing, spreadsheet and typing skills required.

Job pace may be fast and Job completion demands may be high.

Education and/or Experience

Bachelor s Degree plus 3-6 years experience in Biotech maintenance or manufacturing, or AA Degree with 5-7 years of Biotech maintenance or manufacturing experience, or HS Diploma with 7-10 years of manufacturing experience. Minimum of 1-4 years of leadership experience. Scientific or engineering degree preferred.

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.

Employee maybe 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.

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.

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.

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 and meetings

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.

Physical Demand

May be required to push up to 75 pounds.

May be required to pull up to 75 pounds.

May be required to balance occasionally.

May be required to carry items frequently.

May be required to climb frequently.

May be required to use hand / finger feel frequently.

May be required movement of head /neck frequently.

May be required to grip and grasp frequently.

May be required to use hearing occasionally.

May be required to kneel frequently.

May be required repetitive/sustained stooping and bending frequently.

May be required to stand constantly.

May be required to walk frequently.

May be required overhead reaching occasionally.

May be required to visually inspect frequently.

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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.