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Senior Sterility Assurance Engineer

  • GE Healthcare
  • Experienced
  • Posted 7/26/2017 4:40:50 PM
  • 2932383
  • Job Function: Quality
  • Business Segment: Healthcare Global Supply Chain
Location(s): United States; Massachusetts; Westborough

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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:
Technical oversight of established sterile products as well as new product introduction (NPI) related to Bioprocess. This role will have deep domain expertise with sterilization science related to development, validation and routine maintenance of sterile products and processes including terminal sterilization (e.g., radiation, ethylene oxide, and moist heat/steam), related microbiology and sterile barrier integrity testing as well as controlled environments and environmental monitoring.

Essential Responsibilities:
This role is responsible for in-depth knowledge of applicable industry standards and best practices related to sterilization, microbiology and contamination control
Essential responsibilities include, but are not limited to, the following:
1. Technical leadership and oversight of all aspects related to sterile products including the following:
• Development, validation and routine monitoring
• Material and configuration compatibility with the selected sterilization modality (includes maximum dose or treatment studies)
• Sterilization process lethality and product sterility assurance
• Dose mapping validation as related to radiation sterilization
• Sterile barrier integrity over the shelf life of the product
• Bioburden, Sterility and Bacterial Endotoxin testing
• Contamination control including cleanroom operation, behavior and environmental monitoring as well as manufacturing utilities (e.g., purified water and compressed air)
2. Develops and executes sterilization validation protocols and prepares final reports.
3. Reviews and approves validation documentation and test protocols and reports as well as routine monitoring from contract sterilizers, laboratories and contract manufacturing organization (CMOs).
4. Oversight and accountability for sterile product release to distribution.
5. Establishes and continually improve site level procedures related to sterile products, processes and contamination control. Ensure compliance to applicable Global Quality Procedures and Industry Standards.
6. Develops and delivers site level training programs related to sterile products, testing and cleanroom control.
7. Collaborates with Sourcing and Supplier Quality to select, approve and manage sterile suppliers. This includes development of Supplier Quality Agreements, Sterile Processing Agreement and Sterile Contract Manufacturing Agreements.
8. Proactively interfaces with contract sterilizers and laboratories to ensure timely processing, testing, control and resolution of nonconformance or out of specification results.
9. Leads investigation, root cause analysis and CAPA related to sterilization nonconformance reports as well as microbiology and environmental monitoring OOS results.
10. Functions as sterility assurance and cleanroom SME in audits (e.g., customer and regulatory).
11. Participates as a member of the GEHC Sterility Assurance Center of Excellence (COE) and collaborates with other LS Bioprocess sites as necessary.
12. Monitors external environment to maintain pace with relevant Industry trends, standards and best practices.

1. Bachelor of Science in Microbiology, Biomedical Engineering or other related engineering disciplines.
2. Minimum of 6 years of experience in medical products industry directly pertaining to terminal sterilization, microbiology and contamination control.
3. Ability to develop, validate, implement and defend business processes that impact sterilization.
4. Deep domain expertise in sterilization science including:
• Radiation (gamma and ebeam) – ISO 11137 Parts 1, 2 and ISO/TS 13004
• Ethylene Oxide – ISO 11135; and EO/ECH Residual Testing – ISO 19993-7
• Steam/Moist Heat – ISO 17665
• Bioburden Testing – ISO 11737-1
• Sterility Testing – ISO 11737-2 and USP 71
• Bacterial Endotoxin Testing – ANSI/AAMI ST 72 and USP 85
• Sterile Barrier Packaging – ISO 11607 Parts 1 and 2
• Cleanrooms – ISO 14644 series and ISO 14698 series

Desired Characteristics:
1. Risk Assessment of sterile products and processes
2. Demonstrated ability to develop and deliver effective training.
3. Good interpersonal skills and ability to work effectively as part of a multi-functional team.
4. Strong analytical, problem solving and root cause analysis skills to lead and influence others to drive change.
5. Strong technical written and verbal communication/presentation skills adaptable for all organizational levels.
6. Proficiency with Microsoft Word, Excel and PowerPoint
7. Graduate degree in Microbiology, Biomedical Engineering or other natural science discipline
8. Previous leadership experience in a team environment
8. Certified Green or Black Belt
9. Previous participation in Standard Development for Industry Work Groups (e.g., AAMI, ASTM).
10. Experience with Aseptic Processing and Process Simulation Media Fill Validation

Locations: United States; Massachusetts; Westborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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