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Sr Process Engineer II

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

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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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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Sr Process Engineer II

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Job ID SR0043574 Date posted 10/29/2019 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. Process Engineer II.

Under the direction of the Head of Capital, contribute to capital projects and engineering support for operations ad needed.  The selected candidate will be responsible for technical and/or project management leadership of site capital projects.  Utilize engineering and project management principles to properly design, plan, and execute projects across all capital project phases.  The selected candidate will provide operational support as needed to troubleshoot equipment issues, identify the root cause for equipment/process failures and variability; support the engineering teams with technical aspect of investigations for equipment failures association with formulation and filling processes.

Essential Duties & Responsibilities

  • Execute capital and operational projects in the capacity of the engineering lead, and/or project manager as required.
  • Contribute to creation of the Site Master Plan
  • Identify process and equipment improvement opportunities; lead improvement projects through conception, implementation and completion/handover.
  • Perform feasibility assessments for introduction of new processes and modification of existing processes. Make design recommendations.
  • Provide technical expertise for troubleshooting manufacturing process and equipment problems.
  • Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. Contribute to creation of the site capital plan and long range plan.

Qualifications

Key Skills and Competencies

  • Leadership and project management skills. Must have the ability to organize and present technical and project management overviews without assistance.
  • Strong understanding of cGMP manufacturing and GEP.
  • Experience with design, installation, and qualification of cell culture and purification processes
  • Familiarity with Formulation and Fillings processes, equipment and unit operations
  • Familiarity with CIP, sterilization methods such as SIP and autoclave, lyophilizers, filling machines, capping machines and aseptic processing.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
  • Must have good verbal/written communication skills

All Positions:

  • The position requires shift, weekend, and holiday work. 
  • Employee maybe required managing 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. 
  • Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).
  • Support planning and scheduling activities as directed.
  • Requires familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes to include NFPA, NEC, UBC, UMC and UPC in compliance with Takeda EH&S and Factory Mutual requirements.
  • 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 such as CAL OSHA and OSHA.
  • Ensures personal Training Plan execution and compliance. Attends required training, meetings, and QWTs. Interact with and oversee contractor/vendor work
  • Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.
  • Understand ergonomic relationship between people, equipment and working environment.
  • Communication with customers, and daily communication and interaction with Supervisor regarding all daily activities.
  • Adhere to all SOP’s during execution of daily work tasks.
  • May be required to participate on call rotations for facilities/manufacturing/utilities support.
  • Provides support for regulatory, partner and internal audits.
  • May be responsible for development, revision and review of maintenance reports forms, records and/or procedures.
  • Maybe provide training for staff as needed.
  • Living our leadership behaviors is a basic expectation for all employees.

Leadership Behaviors

  • Integrity
  • Fairness
  • Honesty

Education and/or experience

  • Bachelor's degree in Engineering discipline required. 8+ years of related experience.
  • Demonstrated success in delivering capital projects through direct project management or technical leadership.
  • The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams.

Physical Demands

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.

Working Environment

  • 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.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work overtime as required. (only for non-exempt positions)
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.
  • May be required to travel for business reasons, e.g. training or FAT.

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 SR0043574

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