Sterilization Validation Specialist - Primary Talent Partners

Primary Talent Partners has a 12 month contract opening for a Sterilization Validation Technician to join a multinational medical device for an onsite position operating out of Danvers, MA.

Pay: $30.00/hr - $40.00/hr based on experience
Contract: 12 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship

Summary:
This role involves performing sterilization validation, microbiological analysis, and cleaning validation activities in compliance with ISO standards, including ISO 11135, ISO 10993-7, and ISO 11737. The candidate will generate technical documentation such as validation plans, test procedures, and engineering reports while working in a fast-paced environment requiring critical thinking and minimal oversight. They will serve as a technical specialist, conducting tests, analyzing data, and proposing solutions to optimize processes and ensure regulatory compliance.

Responsibilities:

• Performing sterilization validation, microbiological analysis, and cleaning validation activities in compliance with ISO standards
• Performs a variety of technical procedures such as preparing routine solutions and reagents and performing routine reactions.
• Makes and records observations; performs simple calculations; and collects and prepares data for evaluation.
• Conducts laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing glassware.
• Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
• May analyze compounds and manage corporate compound collection.
• Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

Qualifications:

• Bachelor's degree is preferred, though not required. 
• High School Diploma is required. 
• 2-3 years of experience is required with Sterilization Validation/ Microbiology.
• Hands on EO validation sterilization experience and a working knowledge of ISO 11135:2014, ISO 10993-7:2008/AMD 1: 2019, and ISO 11737 series.
• Cleaning Validation.
• Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, and/or validation reports.
• Most importantly, the candidate must be a technical leader, able to handle a project with little to no oversight.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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