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Job Description
Summary:
* This position is responsible for developing and managing the automation strategy, implementation plan and system integrations.Lead scope definition, conceptual design, specifications, budgeting, scheduling, commissioning, and production support.Provide guidance, review, and direction as necessary to create relevant and functional Life Cycle and other documentation in accordance with cGMPs and Takeda Quality Systems standards.Provide guidance and direction to Takeda employees and contractors to meet schedule and financial goals while ensuring technical success.
* Create and manage a department vision that aligns with the organization’s vision or strategic plan.Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff.Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget.
Exhibits creativity and innovation in completing divisional and cross functional/business unit responsibilities.
Essential Duties and Responsibilities:
* Applies state of the art techniques in the area of expertise to develop new or improved products and processes.
* Leads large scale programs and multiple small projects with complex features.
Participates in the execution of Project Record (PR) ownership, DeltaV/EBM/PLC/BAS configuration changes, functional tests, Commissioning Plans, and Qualification Protocols.
* Owns and closes corrective actions related to the automation system; this includes but is not limited to Corrective Action & Preventative Action (CAPA) that are generated due to user interventions and non-conformances/events.
* Leads and schedules activities for Critical Systems PLC and BAS projects to ensure that all automation engineering actions are completed by assigned due dates.
* 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 work.
* Develop and implement new product/process requiring development of technologies
* Plan and schedule project implementation.Responsible for defining scope of work for project team.
* Review and analyze proposals to determine if benefits derived and possible applications justify expenditures.
* Provide guidance and assist risk assessment and validation.
* Execute projects in accordance with the LA Plant Project Management Methodology guidelines and practices.
* Communicate/coordinate with other groups to ensure successful implementation of design.
Qualifications:
* Experience managing automation systems in an FDA regulated manufacturing settings.
* Knowledge of GMPs, FDA guidelines and validation.
* Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
* Must have strong communication skills in order to effectively communicate with all levels of professionals, both internal and external.
* Ability to design and influence outside of immediate scope of responsibility.
Maintain industry contracts and be involved in industry interest groups.
Strong problem solving and trouble shooting skills.
* Preferred 5+ years of experience in process design, controls engineering and process improvement.
* Preferred knowledge of pharmaceutical or food industry, Allen Bradley line of product (PLC, VFD, Panel View), Flex I/O, Compact Logix, Factory Talk SE, Panel Views, Wonderware In Touch.
* Familiar with automation associated with critical systems like RO, WFI Stills, Alcohol still and associated distribution systems, boilers, compressors, multimedia filters, chillers, etc.
* Preferred knowledge of Building automation systems (Siemens Insight or Desigo) required.
Education and/or experience:
* Bachelors’ degree in Engineering discipline required.
5+ years of related
* experience.
Physical Demands:
* Must be able to lift, push, pull and carry up to 25 lbs.
* In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
* 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 and/or 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.
Location and Salary Information: This post excludes CO applicants
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA
– CA
– Los Angeles
USA
– CA
– Van Nuys
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time