Sr Microbiologist-Steriliz

Are you an experienced Sr Microbiologist-Steriliz with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Microbiologist-Steriliz to work at their company in Billerica, MA.

Primary Responsibilities / Accountabilities :

• Responsibilities may include the following and other duties may be assigned.
• Work relatively independently with guidance and direction from senior members of the staff and the 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 sterilisation 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.

Qualifications :

Preferred :