Posted to MedZilla on 1/16/2019


Takeda Pharmaceuticals

US-CA, Manager, Process Engineering SR0031477-MZ


 
 

Under general direction of the Head of Process Engineering, this position is responsible for managing the junior process engineering staff as required, projects and support related to the Los Angeles Plant. In addition, execute independent technical projects in conjunction with managing junior staff. This is a player-coach role. Establish engineering discipline and practices that support the operation of manufacturing while improving process functionality. Lead scope definition /clarification exercises to properly and completely characterize process requirements. Responsible for all process and related functions including conceptual design, specifications, budgeting, scheduling, construction management, commissioning and start up, to ensure effective implementation.

Essential Duties and Responsibilities

  • Coach, motivate, develop, recognize and mentor the junior engineering staff.
  • Create and maintain employee and organizational development; as well as HR plans, which meet the business needs, as needed.
  • Through coaching, direct others to resolve project issues based on own demonstrated success in solving difficult and complex problems.
  • Provide leadership to assess and provide guidance and risk assessments regarding requirements for redundancies to equipment, processes and systems.
  • Applies state of the art techniques in area of expertise to develop new or improved products and processes.
  • Responsible for assigning resources to support manufacturing operations, training initiatives and process engineering projects.
  • Performs financial planning and assists in the analysis to justify project approval.
  • Independently plans, schedules and leads cross-functional team in detailed phases of the engineering support work.
  • Contributes and administers standards, policies and good engineering practices. Responsible for preparation of cost estimates up to multi-million dollar range and contribute to the selection of tactical proposals among several options.
  • Access, analyze, advise, propose and direct improvements that will deliver greater productivity, capacity, reliability and compliance for the process engineering department.
  • Partners with the Maintenance services teams as well as other Engineering Teams to be efficient, effective, proactive and compliant.
  • Review, analyze and direct capital and expense projects to achieve greater equipment and facility reliability, improve process performance and improve product quality.
  • Establish, develop and drive Good Engineering Practices in all projects undertaken and support services provided. Utilize standard methodologies that have been established for project and portfolio management as well as maintenance work order management.
  • Participate in and facilitate the harmonization and coordination of efforts between other teams such as Validation, Manufacturing, Facility Engineering, Maintenance, Technical Services, R&D, EHS and Regulatory.

Qualifications

  • Proven track record of management/leadership effectiveness. Demonstrates strong communication skills in order to effectively communicate with all levels of professionals, both internal and external.
  • Experience in pharmaceutical equipment (e.g. CIP/COP, Column Chromatography, UFDF), as well as design, installation and commissioning of large projects.
  • Expertise in Batch Processing design and scheduling of Process Operations
  • Experience and Understanding of the Design, Build and Validation process.
  • Ability to design and influence outside of immediate scope of responsibility.
  • Provide technical guidance to peers, in terms of problem resolution and process clarification.
  • Proven ability to apply specialized theoretical knowledge in a creative way to a broad range of difficult problems.
  • Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or processes. Plans, executes and functionally directs important engineering assignments, which require independent judgement.
  • Generate innovative solutions to highly complex problems where little clear precedence exists.

Education and/or experience

  • Bachelor s Degree in Chemical, Mechanical or Bio-Chemical Engineering.
  • Minimum 10 years of experience in process design, engineering and process improvement.
  • Minimum of 2 years of experience in managing engineering staff.
  • Scope requires an in-depth knowledge of pharmaceutical or food industry process equipment related to process equipment, and general working GMP knowledge of pharmaceutical manufacturing facilities and all major utilities.

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.
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

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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