Sr. Sterilization Engineer

Summary:

As a subject matter expert candidates must be capable of driving Ethylene Oxide Sterilization (EtO) projects from start to end for both simple medical equipment and complex medical devices with or without external support. Candidates are responsible for formulating designing and performing the Ethylene Oxide Sterilization (EtO) validation in accordance with established procedures and regulatory guidelines. Candidates will also perform the testing of samples using various sterilization platforms while analyzing test results assisting in troubleshooting and generating the sterilization reports. To be a successful sterilization leader you should demonstrate good critical thinking and judgment and great attention to detail. 

Essential Duties/Responsibilities:

• Serves as an expert of EO sterilization.
• Works closely with clients to design the validation plan for hard to sterilize devices. 
• Design complex sterilization study for requalification batch release equivalence study comparative resistance study product adoption and full validation. 
• Draft validation protocols reports deviations exceptions and other relevant regulatory documents.
• Completes work orders based on customer order requests/protocols. 
• Performs testing of biological indicators and records results. 
• Performs inventory and reordering from suppliers. Receives both supplier and customer products. Creates shipping documents when required. 
• Maintains equipment and facility following daily cleaning procedures. 
• Maintains various validation documents files and records. 
• Interprets protocols and executes PQ portion of a product validation process. 
• Must be current with all regulations pertaining to EO sterilization.  
• Comply with Quality Management (QMS) procedures and company policies. 
• Responsible for maintaining the validation plan running cycles and tracking validation project status. 
• Design an initial training plan for new staff and lead refresher training related to EtO sterilization.
• Works as a leader of the Eurofins sterilization team during clients meeting and represents the site while attending conferences.
• Provides scientific feedback and recommendations for microbiology testing requirements product inoculation plan and provides support as a subjectmatter expert on validation and R&D testing related to product validation studies. 

Qualifications :

Education:

• Minimum bachelors degree in science or any related technical field.

Experience:

• Prior managerial experience is preferred but not required.
• 5 years of directly related experience in the sterilization business.
• Knowledge of QA/QC document control laboratory procedures experimental and/or medical and engineering/manufacturing design and development.

Capabilities:

• High degree of organization skills clear and precise written and verbal communication skills.
• Knowledgeable with FDA ISO and other regulations pertaining to controlled documents.
• Administrative support Microsoft Word and Excel experience

Additional Information :

Position is fulltime working MondayFriday 8am5pm overtime as needed.  Candidates currently living within commutable distance to San Jose Ca are encouraged to apply.

Compensation: $120K150K/year

Excellent full time benefits including comprehensive medical coverage dental and vision options

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Fulltime