Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-CA, Head of Maintenance SR0035130-MZ


 
 

Summary

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 Head of Maintenance. 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 Head of Maintenance is recognized within Takeda as a subject matter expert (SME) for the Thousand Oaks Biologics manufacturing facility with respect to all Engineering Operations activities. In this role, he / she is responsible for Integrated Facilities Management, Facility, and Equipment Maintenance and Calibration, MRO parts and their inventory and Utility operations activities within the Site Engineering function.

This position reports into the Head of Site Engineering at the Thousand Oaks manufacturing site. The Engineering Services Associate Director is an integral member of the Site Engineering Leadership Team. He/she also interacts closely with the Operational Managers within the Site OLT at the facility to ensure that all Engineering Services activities are delivered to support reliable and robust manufacturing operations.

The Engineering Services Associate Director ensures that the Engineering Operations team is staffed with the appropriate skills and capabilities to meet all Site Engineering functional goals. He / she establishes Engineering Operations organization focusing on right first time delivery and following industry best practices to meet the strategic needs of the Thousand Oaks Manufacturing Plant. He / she ensures the availability and correct function of all equipment and utilities in a timely and cost effective manner and the reduction of downtime and malfunctions to a minimum.

Lastly he / she ensures that adequate technical and numerical support is provided to the Engineering Services team to assure the success of engineering operations aspects of improvement projects.

Essential Duties and Responsibilities

  • Lead, resource as appropriate and manage the Engineering Services (ES) function ( i.e. Integrated Facilities Management, facility and building maintenance, equipment maintenance and calibration and utility operations and control)
  • Fulfill all relevant external and internal compliance, EHS and quality requirements by focusing on right first time principles and using compliance as a competitive advantage
  • Assure the maintenance of all production equipment, utility supplies, maintenance of instrumentation, the calibration of sensors and measurement equipment.
  • Ensure continuous reliable uninterrupted service for all critical systems that support a 24/7 manufacturing operation
  • Operate Utility Systems and the Waste Water Treatment Plant fulfilling all requirements and applicable Quality and EHS Systems and Policies and ensuring smooth and uninterrupted services for production.
  • Identify opportunities to utilize the Plant s critical systems in a more efficient manner to improve reliability and reduce operating costs.
  • Serve as the site s Energy Manager, create programs to measure and monitor all usage and identify opportunities to reduce energy and lower costs.
  • Organize, review, prioritize, and schedule daily Work Orders (WO) and Preventative Maintenance (PM) work. Efficiently coordinate the workflow and documentation of PMs and WOs. Justify the need for additional resources or outside support when necessary
  • Execute local planning, scheduling and reliability program to pursue the goals to increase operational efficiency and effectiveness, reduce downtime, and achieve industry leading performance in maintenance, calibration, utilities and facilities management.
  • Develop and implement of site procedures and service level agreements to ensure safety and compliance of operation.
  • Identify and lead continuous improvement projects at site with the objective of achieving quality, reliability and cost
  • Develops and Report on key metrics used to monitor progress and develop strategic and tactical plans to advance overall performance.
  • Responsible to guarantee the execution of department task associated with CAPA, calibration deviations.
  • Responsible for the development program of the site team with the purpose to determine and develop strategic competencies.
  • Owner of the local maintenance and calibration system and responsible for application of all relevant SOPs.
  • Manage, coordinate and control the prescribed IFMME partners (ISS and Synovos) to ensure that Takeda requirements and needs are met in a complaint and effective manner.
  • Hire and train the workforce as necessary for the EO function.
  • Develop the ES team to make sure that all reports can fulfill their assigned functional goals and KPIs and contribute to the achievement of the overall Site Engineering Department goals and KPIs
  • Manage shift and emergency response in routine operations
  • Liaise with the Manufacturing Teams and all Support Groups to ensure the fulfillment of production targets and operational effectiveness
  • Responsible for the preparation of the site budget for Engineering Services functions. Fully accountable for assigned ES management and fulfillment of the budget targets
  • Guide, Counsel and Support plant shutdown processes at site to accomplish the intended purpose while minimizing the downtime.
  • Takes part into the Site Operating mechanisms with the goal be fully integrated in the plant routine operations.
  • Responsible to define the spare part plant policy and to guarantee availability of the spare parts
  • Manage assigned projects within the ES function and support other Site Engineering and all other departments at site in the planning and execution of projects
  • Consult and seek alignment with the Plant Engineering, Process Engineering, Automation and Capital Projects functions within Site Engineering to achieve the optimal engineering structure and effectiveness of services delivered to the Manufacturing Plant
  • Consult and coordinate with Engineering Operations representatives within Global Engineering to share lessons learned and best practices
  • Represent the ES function in all internal and external audits
  • Ensure the continuous improvement of all processes and workflows to yield stable, lean and efficient manufacturing and business processes as well as an efficient and lean organization
  • Adhere to any applicable EHS, Regulatory and corporate requirements.
  • Commit to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct.
  • Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan. Partner with reliability engineering to ensure FMEAs are established for all critical systems and drive resolution for any recommendations. Assist as needed in root cause analysis.
  • Ensure a safe work environment is maintained through adherence to safety guidelines and policies. 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.
  • Ensure all mandatory training requirements are met, including annual EHS training, GMP refresher training and any applicable training requirements for all employees.
  • Maintain an on-going two-way performance dialogue with manager and meet timelines for completing all mid and year-end reviews and development plans for self and direct reports.
  • Maintain a positive, professional and customer oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to the supervisor, manager, or human resources.
  • Carry out any other duties as assigned by supervisor.

Qualifications

  • Strong interpersonal skills and communication abilities. Able to manage up and across the organization
  • Apply and communicate to his team members the Takeda Values & Behaviors.
  • Ensure a good integration of the new employees under his responsibility and their training follow up.
  • Define the PMO and follow the PRCP process for the employees under his responsibility in accordance with his direct Supervisor.
  • He / She can be ask to replace the Thousand Oaks Head of Engineering on purpose or during his absence for the following tasks :
  • Delegated meeting
  • Approvals of documents as defined in delegation
  • Representation of the Engineering Services department
  • Leadership experience; good people management skill
  • Excellent in systematic trouble shooting and problem solving skill
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical understanding
  • Must have technical knowledge and experience in plant maintenance and facilities management
  • Business acumen

Education and/or experience

  • Min. Degree holder in Engineering discipline with > 10 years working experience
  • A strong manager capable of providing leadership to teams of Engineers and Technicians
  • GMP systems, plant maintenance or facilities management - required
  • Thorough knowledge of current Good Manufacturing Practices (cGMP)
  • Experience in Manufacturing and Pharmaceuticals (Bio-pharma) preferred

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.