Job Description

Sr. Sterilization Engineer

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

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 subject-matter expert on validation and R&D testing related to product validation studies.

Qualifications

Education:

• Minimum bachelor's 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 full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to San Jose, CA are encouraged to apply.

Compensation: $120K-150K/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.

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