Senior Sterility Assurance Adviser
Location:
Marlborough , Massachusetts
Posted:
June 27, 2017
Reference:
2706349
About Us:

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

GEHC - LS

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . 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:

This is a key technical leadership position, affecting sterility assurance for established sterile products as well as NPI products as pertains to medical devices, pharmaceuticals and bioprocess products. This role will have deep domain expertise related to sterile products and processes including Terminal Sterilization (e.g. EO, Radiation, and Moist heat/steam), Aseptic Processing (e.g., sterile filtration and lyophilization), controlled environments and related Microbiology testing.

Essential Responsibilities:

This role will be responsible for in-depth knowledge of applicable industry standards and best practices related to sterilization and microbiology (e.g., AAMI, ISO USP, EP GMPs, PIC/S).

Essential Responsibilities include (but are not limited to):

1. Establish, improve and implement global sterility assurance procedures and best practices.

2. Develop and effectively convey training programs related to sterilization, Microbiology and controlled environments. Coach and develop team members.

3. Track external environment trends, influence industry standards by participation in relevant industry working groups and provide expertise and guidance on regulations and standards.

4. Improve supplier quality performance for sterile suppliers via Quality Plan implementation.

5. Approve supplier selection through robust qualification processes including those related to terminal sterilization and aseptic processing.

6. Assure supplier compliance to GEHC QMS and regulatory requirements through supplier monitoring process

7. Establish networks and develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers.

8. Interface with Suppliers, Engineering, Service, Manufacturing, Sourcing and site Sterilization and Microbiology personnel to drive Quality improvements that assure sterile products and minimize Costs of Quality

9. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with CAPA process.

10. Provide direction as Subject Matter Expert (SME) for sterilization processes, compliance and standardization improvements supporting internal and external activities.

Qualifications/Requirements:

1. Bachelors Degree in Microbiology, Biology, Biomedical Engineering, Chemistry or other natural science discipline.

2. Minimum 10 years of experience in medical device and/or pharmaceutical manufacturing of sterile products (plant and division level), sterility assurance, quality assurance or regulatory affairs

3. Demonstrated experience with communicating and teaching industry standards and best practices.

4. Proficiency with Microsoft Word and Excel Spreadsheet development and analysis.

5. Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross functionally and globally).

Desired Characteristics:

1. Ph.D. in Microbiology, Biology, Biomedical Engineering, Chemistry or other natural science discipline.

2. Industrial Sterilization of medical products.

3. ASQ Certified Quality Engineer

4. Certified Green Belt (Certified Black Belt preferred)

5. Previous leadership experience

Locations: United States; Massachusetts; Marlborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf . 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.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion​ of a background investigation and drug screen.

A little about us:
GE imagination at work.

Know someone who would be interested in this job? Share it with your network.