Sterility Assurance Leader/Specialist (Remote)

Thermo Fisher Scientific Petaluma, CA

About the Job

Job Title: Sterility Assurance Leader

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.

Location/Division Specific Information
Division: Laboratory Plastics Division.
Location: Remote USA

How will you make an impact?
Under the direction of R&D Research Manager, the Sterility Assurance Leader will be responsible for acting as a core team member in projects involving radiation (gamma and e-beam) and ethylene oxide sterilization of commercial laboratory consumables, including medical devices.

What will you do?
You will report to R&D and support Manufacturing Operations / Supply Chain as needed. Working closely with Sourcing and Operations leaders you will develop and execute our Sterilization strategy. You will also work closely with sterilization suppliers, technicians, engineering, project managers, product managers, and packaging engineers to ensure that the product specific sterilization processes are properly validated and documented. This role will need to have effective time management and multi-tasking skills and have a team player mindset.

Acts as subject matter expert on sterilization validations for projects involving: New product introduction; Supply Chain Sterilization Optimization; New supplier qualifications; Risk assessments and test plans for product and/or process changes affecting sterile products
Participate in investigations and CAPA implementations
Generate sterility and shelf-life validation documentation such as protocols and reports
Ensure that sterilization studies conform to the most current internationally recognized standards and applicable regulations .Coordinate testing (bioburden, stability studies, etc.) and maintain related documentation. Work closely with contract sterilization providers for routine sterilization process development
Review quarterly dose audits and annual re-validations. Initiate investigation upon any failures. Project lead for any actions stemming from investigation
Support customer, notified body, and regulatory audits as needed. Assist in the update of QMS procedures as needed (multiple sites)
Coordinate sterilization plans to incorporate long-term and short-term strategic planning for sterilization in the division
Participate in external audits relating to sterilization, as needed. Assist with OOS (out of specification investigations) relating to bioburden, sterility, or environmental excursions on the manufacturing floor . Provide regular project status updates to leadership team
Up to 20% travel (some international) may be required

How will you get here?
Minimum Bachelor’s degree in Science or Engineering (preferably Microbiology, Biochemistry, Biology, Chemistry, or related field)

Minimum 7 years related sterilization experience.
Experience in regulated environment (cGMPs, ISO 13485, ISO 9001, etc.)
Experience with stability studies
Experience with sterilization of medical devices
Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics