Thermo Fisher Scientific Sr. Sterility Assurance Leader, LPE in Grand Island, New York
Job Title: Sr. Sterility Assurance Leader, LPE (Laboratory Plastics Essentials)
Requisition ID: 132824BR
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
This role will be remote (work from home) but this individual will need to be easily accessible to the Rochester, NY sites for traveling purposes as necessary. Up to 50% travel (some international) altogether may be required.
How will you make an impact?
The Senior Sterility Assurance Leader will be responsible for overseeing the ethylene oxide and radiation (gamma and e-beam) sterility assurance programs that encompass both R&D and Operations relating to sterile laboratory plastic consumables, including medical devices. The Senior Sterility Assurance Specialist will engage with Engineering, Scientists, and Quality to ensure that sterilization validations are adequately documented and follow internationally recognized standards and applicable regulations. The Senior Sterility Assurance Specialist will also work to develop and maintain global guidance documents for LPE sites to use and implement into their quality systems.
What will you do?
Review and approve sterilization validations and re-validations for LPE products in Europe and North America
Support customer, notified body, and regulatory audits as needed
Ensuring that sterilization studies conform to the most current internationally recognized standards and applicable regulations
Act as quality representative for sterilization projects
Providing direction and oversight to Scientists, Specialists, and Engineers
Provide guidance to sterility specialists on project planning and execution
Work with both R&D and Site Operations on resolving issues related to sterilization and / or contamination
Long-term and short-term strategic planning for sterilization in the division
Conduct internal and external audits relating to sterilization, as needed
Communicate updates to executive leadership on sterilization projects
- Bachelor's degree in Science or Engineering - preferably Microbiology, Biology, Chemistry, Biochemistry or related field; excessive experience in lieu of degree may be acceptable
Minimum 5+ years' related sterilization experience
Supervisory background is preferred (will have direct reports in the future)
Experience in ISO 13485, ISO 11137 and FDA medical device sterilization is required
Work experience with stability studies
Knowledge, Skills, Abilities:
- Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.