Senior Microbiologist (Sterilization)

Description: This role will be a key team member of the Surgical Innovations in the EU-MDR remediation effort. The candidate will work in a fast pace environment and is expected to have optimal critical thinking skills and audit readiness mindset to succeed in this role. The Senior Microbiologist-Sterilization will be responsible for the sterility assurance EU-MDR remediation efforts by meeting the objectives detailed below:

Objective # 1 - Locate Sterilization Validation Documentation:

• The candidate will be given a list of product part numbers in scope for EU-MDR remediation. The candidate is expected to search within the multiple product life cycle management systems for each product part number on the EU-MDR list to locate validation documentation for sterile devices.
• The candidate will create a list of all sterilization validation documents found for each product part number on the EU-MDR list.

Objective # 2 - Review Sterilization Validation Documentation:

• Once validation documentation has been located within product life cycle management system review for compliance alignment to applicable International Standards ISOs and guidance documents.
• For sterile disposable products review sterilization validation documentation against the requirements of applicable sterile method ISOs ISO 11135 ISO 17665 ISO 11137 or ISO 14937

Objective # 3 - Close identified compliance gaps:

• For sterile product part numbers with identified compliance gaps in terminal sterilization lead efforts to remediate gaps by planning executing and managing sterilization validations at contract sterilizers and laboratories. Includes protocol and report writing.

Objective # 4- Prepare deficiency responses as needed for EU MDR submissions:

Responsibilities may include the following and other duties may be assigned.

• Analyzes chemical biological or microbiological products raw materials in process materials release test samples or stability samples in support of the company's quality program.
• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Develops validates and implements controlled environment methods.
• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency or devises and develops new analytical methods and techniques.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology.

Qualifications:

• Education Required: Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience
• 4 years applied experience in radiation sterilization and ethylene oxide sterilization specifically execution of validations
• Environmental Monitoring EM subject matter expertise.

Questions? Reach out directly to Morgan Johnson -

• mfinch @actalentservices.com
• (763) 923-2083

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Salary : $45 - $50