Senior Microbiologist

Primary Talent Partners has an exciting opportunity for a senior microbiologist with our large medical technology client.

Please see details below and apply if qualified and interested!

Logistics: 
Client: Large Medical Technology Company
Job Title:  Senior Microbiologist
Length: 7-month contract
Location: Billerica, MA
Schedule/Hours: 40 hrs/wk, M - F
Pay Range: $60/hr to $70/hr, no PTO or benefits included. An ACA-compliant benefits package is available for enrollment.

 *****Please only apply if you are available to work on our W2 (No corp to corp, 1099, or sponsorship available) 

Job Overview:
HM's Top Needs:

1. Practical experience with sterilization, microbiology and controlled environments. Standards and guidelines applicable for this role include, but are not limited to, ISO 11135, ANSI/AAMI ST72, ISO 11737-1 and -3, ISO 17664, ISO 17665, ISO 14644 (series), EN 17141.
2. Ability to think critically to develop complex plans and execute actions according to plan
3. Self sufficient and able to drive completion of work with minimal guidance/direction

• Certified Industrial Sterilization Specialist (CISS)
• Experience in Ethylene Oxide Sterilization validation
• Thorough knowledge of fundamental microbiology principles, methods, and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
• Environmental Monitoring (EM) subject matter expertise.
• Expertise in clean room requirements and gowning requirements
• Ability to multi-task, skilled in planning, organizing, coordinating projects, and working independently.
• Ability to write protocols, reports, procedures, and work instructions
• Ability to read and interpret documents related to medical device sterilization and cleanrooms Including: International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with FDA regulations.
• Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project
• Expertise in cGMP's and quality systems as related to terminally sterilized medical devices.
• Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques, including: ISO 13485, 11135, 14644 (series), 14698 (series), 17665, 17664, 11737-1/-2/-3, and ANSI/AAMI ST72.

• Work relatively independently with guidance and direction from senior members of the staff and manager.
• Assure all Quality requirements are in compliance with regulations and product specifications
• Provide new product development sterilization / microbiology validation support
• Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO)
• Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Healthcare.
• Support the development and validation of cleaning, disinfection and sterilization of reprocessable devices
• Support internal and external audits
• Prepare written responses to regulatory questions
• Review engineering change orders.
• Resolve non conformances and implement corrective action
• Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
• Participate in special projects as assigned.
• Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing.
• Assuring that the Microbiology / Sterilization function is maintained per industry standards.

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  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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