Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-CA, Instrumentation Manager SR0034919-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 Instrumentation Manager. The selected candidate must provide thought leadership and demonstrated ability to coach and influence at the executive level and across the broader organization. In addition, the selected candidate must have a proven track record of ensuring safety, quality, delivery and cost are achieved in support of the business strategy.

Summary

Under minimal direction, the selected candidate manages, plans, and supervises the facility, utility and equipment calibration programs for both operations and QC. The selected candidate is responsible for supporting all calibration efforts including repair, troubleshooting, and new installation. Responsible for managing and coordinating metrology activities to maintain optimum operation of facility and production equipment in full compliance with SOPs, cGMPs, and FDA regulations.

Essential Duties & Responsibilities

  • Responsible for scheduling, prioritizing, assigning and overseeing the calibrations and maintenance activities
  • Responsible for calibration service and contract agreement
  • Responsible for quality service of the vendor calibrations. Ensure outside calibration laboratory is accredited or certified
  • Manage the Metrology team to meet the customer needs according to Takeda Standards, these requirements include but are not limited to safety, compliance, completing tasks on time to minimize equipment downtime, spare parts control, resource allocation, off-hours support, effective communication, quality of work.
  • Supervisory duties such as conducting employee performance reviews, development plans and timecard management applies.
  • Responsible for interfacing with all other departments (i.e.; QA, QC, Regulatory, Cell Culture, Engineering, Validation, Purification, Formulation/Filling) in regards to facilities maintenance and calibration.
  • Support all internal and external audits as needed
  • Manage the Metrology Calibration Database Blue Mountain . Create the Month-End report analysis for completed calibrations, Out of Tolerance conditions, Missing Instrument, Pareto Charts, etc.
  • Manage Change Notices for the Metrology Department, which includes routine Calibrations, Preventive Maintenance and equipment upgrade improvement opportunities. Manage equipment/instrumentation specification documents.
  • Managing the work order system JDE C3ME for non-routine calibration schedules, new calibration requests, and preventive maintenance. In addition, manage the aging work orders past 60 days accordingly.
  • Support daily manufacturing operations through the provision of production documents, procedures, files and/or data for electronic business systems/applications.
  • Support 483 cascade evaluations and documentation.
  • Support Internal/External audits for Metrology.
  • Oversee the department s Training Program including: Module Development, Training Plans, Proficiency Audits, weekly training reports, and supports all NCRs actions related to training.
  • Participate in the completion of special projects as necessary.
  • May perform other duties as assigned.

Qualifications

  • Knowledge of Calibrations Database Blue Mountain - Regular Asset Management (RAM).
  • Knowledge of Maintenance work order systems JDE C3ME.
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Exceptional organizational skills and ability to plan and implement resolutions to technical problems. Familiarity with auditing techniques, interpreting regulations and quality systems.
  • Fundamental understanding of change control practices for major manufacturing equipment, critical systems, instrumentation, and computerized systems
  • Working knowledge of manufacturing equipment and systems maintained by all the Plant Services departments (Maintenance, Metrology, Process Automation, and Engineering) or demonstrate knowledge of similar equipment and systems at a similar manufacturing facility.
  • Experience using the following software programs and databases recommended: Word, Excel, PowerPoint, LIMs/Crystal Reports, Minitab statistical software.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Advanced word processing, spreadsheet, and typing skills.
  • Knowledge of Good Manufacturing Practices (cGMP).
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must have passion to innovate and drive for solutions.
  • Must display personal accountability for results and integrity.
  • Must display eagerness to learn and continuously improve.
  • Must have uncompromising dedication to quality.
  • Must have relentless focus on rapid and disciplined action.
  • Must have respect for individuals and the diverse contributions of all.

Education and/or Experience

Bachelor s degree with 5-8 years of experience in Pharmaceutical Manufacturing related to Metrology field.

2-4 years experience directly managing staff.

Physical Demand

  • May be required to utilize proper techniques to safely lift up to 55 pounds occasionally when assisting with the calibration process.
  • May be required to utilize proper techniques to safely push up to 450 pounds occasionally when assisting with the calibration process.
  • May be required to stand and walk frequently to access other areas in the facility.
  • May be required to climb stairs rarely. Elevator access provided to 2nd floor work area.
  • May be required to move head /neck frequently when communicating with co-workers/customers, answering the phone, and filing.
  • May be required to grip and grasp frequently when using computer mouse.
  • May be required to drive occasionally to the Westlake Village or Los Angeles facility for training and meetings.
  • May be required to use hearing frequently when communicating with personnel in person or on the phone
  • Gowning in controlled areas.

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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