Director, Engineering and Validation

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 15, 2020
Ref
R0015314
Required Education
Doctorate/PHD/MD
Position Type
Full time

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated individual for the role of Director of Engineering and Validation to work in this exciting new area of cancer immunotherapy! This role has the primary responsibility for the oversight of the Engineering and Validation organization at our Commerical Manufacturing Location in El Segundo. This role reports directly to the Head of Facilities and Engineering at the site.

Responsibilities (include but not limited to):

  • Builds and manages an effective Engineering and Validation team and ensure that all personnel are fully aligned to their customer needs and requirements, providing an excellent level of service.
  • Responsible for staff development, and managing high performing teams budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function, and multi-function for long-term planning
  • Leads the day-to-day activities of an engineering and validation department.
  • Resolves people management issues and provide expert advice to managers regarding technical, operations or people management issues.
  • Manages the site Capital Project Portfolio and budget for the Engineering & Validation department.
  • Manages the site Capital Project execution process and delivery in alignment with organizational goals and in compliance with corporate policies and in collaboration with Corporate Facilities and Engineering
  • Manages the site Validation Master Plan, Requalification and Periodic Review programs for equipment, facilities and utilities
  • Responsible for Asset Lifecycle Management program and Asset Reliability program
  • Provides oversight and support for Engineering and Validation Programs to ensure Safety and GMP Compliance
  • Develops, reviews, modifies, implements and recommends modifications to company- wide Engineering and Validation policies and procedures to achieve corporate goals and objectives.
  • Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Develops requirements and specifications for projects and ensures that business drivers are clearly defined and communicated.
  • Directs the development of strategic function programs/initiatives, determines metrics for program success, and evaluates performance against metrics.
  • Analyzes industry trends and anticipates changes in the competitive or regulatory landscape to adjust plans as appropriate.
  • Ensures projects are executed safely, efficiently, and in accordance with all applicable codes and Kite/Gilead Standards.
  • Serves as team representative in strategic planning and operating discussions with senior leadership.
  • Collaborates with the Global Facilities and Engineering Network to enable development and implementation of company best practice for engineering, industrial automation and validation topics.
  • Other engineering and validation related services for permanent or ad hoc requests.

 


Requirements:

 

 

  • Minimum required education/experience for BS + 12 years, for MS +10 years or for PhD + 8 years.
  • At least 8 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence or Lean manufacturing principles
  • Minimum of 8 years of people management experience
  • Develops solutions to problems of moderate complexity, which require a high degree of ingenuity, creativity and innovativeness.
  • Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Kite in public forums.
  • Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities
  • Up to 10% travel required

 


Additional Qualifications:

 

 

 

  • Advanced Engineering Degree highly desired.
  • Project Management certification or equivalent is a plus
  • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for cell therapy and pharmaceutical
  • Able to express ideas and present information effectively to Kite leadership, within team functions, and with external partners
  • Ability to think critically with demonstrated troubleshooting and analytical skills

 


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.