Posted to MedZilla on 5/20/2019

Takeda Pharmaceuticals

US-CA, Instrumentation Manager SR0035093-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. The selected candidate, with minimal direction, will lead, manage, plan, and supervise the facility, utility and equipment calibration programs for both operations and QC. Responsible for supporting all calibration efforts including repair, troubleshooting, and new installation. The selected candidate is 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 requirement include but 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.
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.

Essential Functions

Define group objectives in alignment with Plant Services Department and Global Engineering Team

Track and routinely present group performance objectives to Senior Management

Responsible for preparing budget, overall spending in Reliability Engineering cost center and meeting forecasts.

Participates with Maintenance Management team to develop and improve processes and operations in maintenance functions.

Support, review, assess and counsel engineering project teams regarding all areas of maintenance impact; such as, layout, design for maintainability, component standardization and spare parts/ material optimization.

Participates with Operations to development and improve Equipment Reliability, Preventive/Predictive Maintenance, and CMMS Data Collection and Operation.

Participate in internal and external regulatory audits, including FDA,EMEA and OSHA.

Perform regular reviews with Reliability Engineering Staff to ensure personnel performance and development.

Interact with Global Reliability Engineering team to build standards across the network and provide input to Divisional Procedures.

Extensive experience with current best practices for asset management including, Preventive Maintenance, Reliability Engineering, RCM, FMEA etc.

Successful track record of managing wide-ranging activities within a business unit.

Manage, identify, hire, develop and recognize staff of Maintenance Reliability Engineers

May perform other duties as assigned.

Education & Experience Requirements

B.S in an Engineering field is required.

Must have 8-10 years of overall Engineering experience and at least 3 years of experience leading engineering projects for an FDA regulated facility in a cGMP environment.

Key Skills and Competencies

Demonstrates leadership skills.

Knowledge of cGMP manufacturing.

Thorough understanding of international Regulatory requirements for pharmaceutical Maintenance Systems.

Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.

Must have proficient computer skills and be experienced using CMMS systems. Experience with JD Edwards desired.

Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.

Must be a self-starter, detail oriented and able to work independently with minimal supervision.

Must embrace working in a fast-paced, team-oriented, cross-functional environment.

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.

Leadership Behaviors

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

  • Be Positive
  • Be Accountable
  • Be Results Oriented
  • Be An Excellent Manager of Self and Others

Other Job Components

Working Environment

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.

May be exposed to sunlight and heat, may work in a cold and wet work environment.

May be exposed to dust, gases, and fumes.

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 work around chemicals such as alcohol, acids, buffers that may require respiratory protection.

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

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

This position requires shift, weekend and holiday work.

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

Possible exposure to cool/hot storage conditions.

Will have interaction with other people.

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

Physical Demand

Must be able to lift, push, pull and carry up to 50 lbs.

In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

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 -

EEO is the Law Supplement -

Pay Transparency Policy -

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.

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