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Senior Reliability Engineer

Thousand Oaks, California

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Senior Reliability Engineer

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Job ID SR0043400 Date posted 10/24/2019 Location Thousand Oaks, California

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 Sr. Reliability Engineer.

The selected candidate is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment Support capital projects as needed. Supervision of junior staff. May be assigned other duties.

Essential Duties & Responsibilities

Individually perform, lead teams or supervise staff with:

•Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.

•Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.

•Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements

•CMMS data reliability and integrity improvement.

•Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO

•Perform functional equivalency assessment of spare parts.

•In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment.

•Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).

•Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.

•Participate and provide support for audits.

•Lead the implementation of predictive maintenance across the facility

•Supervise and mentor junior staff

•Develop business case for improvements requiring investments and participate in capital planning for assigned area.

•Lead, participate, and provide subject matter expertise in the design review and selection of new equipment.

•May participate in FAT, Commissioning of new and modified equipment

•Manage contractors as needed

•Identification of cost/waste/energy reduction projects

•May perform other duties as assigned

Qualifications

•cGMP experience is desirable

•Ability to lead teams and multiple small and medium projects at the same time

•Must have knowledge of CMMS and engineering & maintenance business practices / procedures

•Must possess knowledge of laboratory and pharmaceutical production and support equipment, including utilities and critical systems (Cell Culture, purification, aseptic filling, packaging, CIP, SIP, HVAC, plant and clean utilities)

•Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project.

•Must possess strong knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics.

•Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.

•Must be organized and detail focused.

•Knowledge of chemical and biological safety procedures.

•Understanding of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable

•Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, SixSigma / DMAIC, FMEA is desirable.

•Under supervision, able to organize and present technical and project management plans, schedules and budgets.

•Must possess good organizational, verbal and written communication skills;

•Membership of relevant professional / technical organization is desirable

Education and/or Experience

•B.S. in Engineering

•3 - 5 years of relevant engineering experience.

Working Environment

May be required to travel for business reasons, e.g. training and meetings

•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 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 and celite that may require respiratory protection.

•Inside working conditions.

•May require immunization before performing work within the manufacturing area.

•Will have interaction with other people.

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

Physical Demand

May be required to visually inspect frequently when completing the following job duty: drawing verifications, field verifications, equipment verification, spare parts verification, start-up, troubleshooting, inspection and commissioning of equipment.

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.

Job ID SR0043400

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