Principal Microbiologist

Position Summary:

The Principal Microbiologist-Sterilization Specialist interfaces with diverse cross-functional team members to define and oversee environmental and sterilization control policies to assure that our medical devices consistently comply with microbiological and particulate contamination control requirements, standards, guidelines and industry practices, both domestic and international.

Responsibilities

• Develop and executes sterilization validation protocols, manage work, document results in reports for contract ethylene oxide sterilization and radiation methods (ISO 11135 & ISO 11137): process definition, characterization, and validation.
• Provides microbiological technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
• Ensures compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices. Assures compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control, and conducting necessary microbiology related training.
• Conducts OTR (Out of Tolerance Result) investigations, establishes actions to address OTR and reviews output of OTR Investigations with Quality Management.
• Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers. Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
• Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
• Assures timely, accurate and independent evaluation of product compliance to sterilization, and microbiology requirements.
• Supports Regulatory Affairs and other departments by providing technical input on sterilization, and microbiology related content of regulatory submissions and departmental procedures.
• Willing to travel with minimum advanced notice.

• College Degree in Microbiology, Chemistry, or similar field - Requires a University Degree and minimum of 10 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
• Certified microbiologist or Certified Industrial Sterilization Specialist.
• 10+ year's industrial microbiology experience in the Medical Device or Pharmaceutical industry.
• Working knowledge of statistical techniques
• Knowledge of applicable ASTM, ISO, FDA and EN regulatory standards.
• Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
• Computer proficiency using word processors, spreadsheet, and project management.
• Able to apply advanced scientific principles.
• Good oral and written communication skills. Excellent presentation skills.
• Must be able to handle multiple tasks/projects and manage business unit priorities accordingly.

Top 3 Needed Skills:

1. 10+ years applied experience in contract ethylene oxide and radiation sterilization, specifically execution of validations and optimization of cycles (ISO 11135 and 11137)
2. Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
3. Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently