Director, Process Engineering

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The Director, Process Engineering, will provide leadership and direction to the Engineering organization supporting Operations. This role is responsible for managing the strategic and tactical process and equipment direction associated with daily events and issues to keep plant on track. This individual will identify and address systemic issues affecting operations, and be accountable for coordinating responses to all events affecting safety, quality and plant performance. This individual will also be engaged in proactively evaluating and preparing the organization for upcoming activities – New Product Introductions and Growth.

  • Oversees and leads data management and process monitoring review of processes. Leads process validation and verification efforts.
  • Ensures reliable and high quality on-the-floor technical support to production and quality. Provides
    technical leadership in equipment and process-related investigations
  • Supports the creation of the work instructions and ensures manufacturing operations stay aligned with validated processes.
  • Maintains the process control strategy and operating control strategy.
  • Defines relevant operational and technical standards and practices for the site and serves as an engineering liaison with Product Design and Development to ensure processes and designs are compatible.
  • Oversees identification and implementation of commercial process and product life cycle improvements.
  • Identifies and drives implementation of improvements to maximize yield, throughput, and capacity utilization.
  • Defines and executes Cost Improvement Projects to drive Gross Margin.
  • Fosters continuous improvement in technical knowledge of biotechnology based manufacturing
  • Acts as the primary sustaining engineering liaison with Consumables Specialist Engineering Teams, as required, to ensure the plastic parts running on the lines are compatible with the manufacturing lines
  • Acts as the primary sustaining engineering liaison with Automation Engineering teams, as required, to maintain/improve operation and efficiency of manufacturing lines
  • Ensures all department personnel, including contractors, consultants and temporary employees, directly or indirectly supporting a GMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
  • Ensures individual training and learning plans are kept current and that employees complete and document all required initial and continuing training in accordance with corporate training standards.
  • Builds a broad skill based team with necessary back-ups and coverage to support a 24x7 Operation
  • Bachelor/Master in Life Sciences or Engineering. Or, equivalent combination of education and experience to perform at this level.
  • 10 or more years of progressive leadership experience in the biomedical/hi-tech industry or equivalent.

  • Demonstrated understanding of Product Development Process development, scale-up and validation.
  • Experienced in technical transfer of processes at the commercial and/or pilot scale.
  • In depth knowledge of process engineering and equipment development and their practice in a commercial manufacturing operations.
  • Ability to identify cost improvement opportunities and generate NPI.
  • Effectively understands the relevance/importance of regulatory requirements.
  • Excellent problem solver and ability to generate innovative solutions to broad range of issues.
  • Good understanding of experimental design and statistical process evaluation.
  • Ability to evaluate new technologies/techniques.
  • Excellent people leadership and change leadership skills.
  • Excellent communication skills and ability to influence across the broadest of constituencies.
  • Ability to set ambitious and realistic targets, drive for results and build accountability.
  • Ability to explain complex technical issues to other functions in clear and understandable terms.

 

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