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Supervisor, Global Utilities (HYBRID)

Company: Seres Therapeutics, Inc.
Location: Cambridge
Posted on: March 15, 2023

Job Description:

Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.OurSER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
Seres Therapeutics is a member of the Flagship Pioneering family of companies.
Position Summary
This position will be part of the Global Engineering & Maintenance (GEM) team reporting to the Associate Director, Global Maintenance. The Global Utilities Supervisor role will play a critical part in building the Seres' organization in support of both commercial and clinical manufacturing in close partnership with Quality, Manufacturing Operations, Donor Operations, Validation and Engineering. Working closely with the Associate Director Global Maintenance and peers, this role will be responsible for all GxP utility systems and maintenance activities across the Seres network. The role will be responsible for establishing industry leading processes and capabilities in support of GxP activities. Additionally, the position will be a Subject Matter Expert (SME) support various quality initiatives such as Deviations, CAPA and Change Controls. This role will be based in Cambridge with global responsibilities, and an estimated 15% amount of travel outside of the greater Boston area per year.
What You'll Do

  • You will be responsible for leading the rapidly growing Global Utilities Maintenance team, including recruiting and employee development.
  • Manage the team responsible for establishment of Global utilities, clean utilities, purified water systems, HVAC equipment, instrumentation, and maintenance programs, standards, and procedures for GMP manufacturing facilities.
  • Partner with the Validation and Quality Validation teams to ensure clean utilities are maintained in a validated state.
  • Coordinate work performed on global utilities, clean utilities, purified water systems, HVAC equipment, instrumentation and equipment by external suppliers and vendors.
  • Lead and develop the strategy to optimize the maintenance support model for Global Utility Systems
  • Ensure the effectiveness of the preventative maintenance (PM) and calibration program of instruments, clean utilities, and plant systems.
  • Author preventative maintenance job plans and SOPs.
  • Identify areas to implement predictive maintenance on Utilities systems.
  • Act as SME in support of engineering capital projects, deviations, CAPA and change control as needed.
  • Support the establishment of a clear and inherent culture of Quality First and Right First Time that ensures high transparency and collaboration between Quality, Operations and MSAT such that we work daily as one team in service of bringing Seres' transformative therapeutics to patients, ensuring high quality, responsiveness and value.
  • Demonstrate and coach your team to have a continuous improvement mindset and exhibit strong accountability and technical ownership of the Global Utilities.
  • Coach and mentor, your team to achieve a high performance, quality- and safety-focused maintenance culture.

    What You'll Bring

    • Bachelor of Science degree in engineering, science, leadership or, 5+ years of GxP Facilities, Engineering, Maintenance, and/or Planning & Scheduling leadership experience.
    • GxP Facilities experience, including clean utility, instrument calibrations and process equipment maintenance, Building Management Systems (BMS), Computerized Maintenance Management Systems (CMMS).
    • Experience with GxP facilities maintenance, service contracts and spare part tool room.
    • Working knowledge of FDA regulations, fundamental principles, and operating implementation of electrical, HVAC, process heating and cooling utilities.
    • Specific knowledge of equipment reliability principles and processes as related to maintenance practices.
    • SME knowledge of clean utilities purified water, water for injection, pure steam and maintenance of a GxP facility.
    • Strong ability to collaborate and build productive relationships with team members and stakeholders across the organization; leads by example.
    • Excellent verbal and written communication skills; ability to interface with all levels of the organization.
    • Place a strong emphasis on sustaining and improving our safety culture to help further develop existing EHS program, while simultaneously providing guidance and leadership to the Utility and Maintenance teams.
    • Demonstrate leadership in building and developing high-performance technical and cross-functional teams that can rise to the challenge to deliver for patients with un-met medical needs.
    • A growth mindset and passion for building something new with a talented team, in service of bringing breakthrough medications to patients.

      Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

Keywords: Seres Therapeutics, Inc., Cambridge , Supervisor, Global Utilities (HYBRID), Other , Cambridge, Massachusetts

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