Principal Microbiologist (Hybrid) - Merrimack, NH

Job Overview

This position provides an opportunity for career growth while ensuring the quality, safety, and sterility assurance of cardiovascular medical devices and accessory products.

The position will provide a technical resource to lead or support projects relating to Sterilization, Microbiology, and Cleanroom Operations. The Principal Microbiologist will facilitate the implementation of company policy and strategies with respect to product cleanliness, sterilization, and cleanroom operations. Additionally, he/she will support new product development, collaborating with Product Development Teams and suppliers to provide design inputs for microbiological quality and sterilization requirements. The position will support and drives validation activities for sterilization and cleaning processes and evaluate new technologies and test method changes related to sterilization and microbiology He/she will be responsible for compliance to applicable Quality Regulations, ISO and AAMI standards.

Job Responsibilities and Essential Duties

• Drive compliance of programs and procedures for microbiological activities (Sterilization, Environmental Controls).
• Monitor industry regulatory standards and guidance (AAMI/ ISO/ USP, EP, PDA,). Perform standard assessments as required and interpret requirements into site level programs. Represent Getinge in AAMI standard development committees.
• Support EUMDR and FDA product submission activities. Provide technical documentation and responses to notified bodies.
• Develop and implement strategies to internalize Microbiological and Environmental Monitoring testing programs
• Develop risk based approach methodologies to evaluate and continuously improve BET, bioburden, contamination control, and sterilization programs.
• Provide a technical resource for evaluating alternate sterilization technologies, contamination control, and process monitoring.
• Develop and refine strategies and methodologies for microbiological testing, cleaning validations.
• Collaborate with other Getinge sites to facilitate the harmonization of best practices and leveraging technologies across business units.
• Support the Merrimack QMS improvement initiatives related to Sterilization and Clean room processes including Risk Management updates

Minimum Requirements

• Minimum of Bachelor of Science in Biology, Microbiology, Chemistry or related field is required.
• A minimum of seven (7) years or more experience managing microbiological studies in the medical device or pharmaceutical organization is required.

Required Knowledge, Skills and Abilities

• Strong knowledge and experience in several of the following areas of competency: terminal sterilization, aseptic processing, VHP, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
• Experience with ISO class 8 clean room operational and qualification principles. Experience with ISO class 5 clean room is preferred.
• Demonstrated working knowledge of current industry standards related to sterilization and microbiology such as: 11135, 10993-7, 11137, 17655, 11737 , ST72, 14698, 14644 , 17141. Knowledge with biocompatibility 10993 series is a plus.
• Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
• Must demonstrate effective organizational skills and ability to manage multiple projects.
• Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.

.

Supervision/Management of Others

• Responsible for the development and management programs related to sterilization and microbiology

Internal and External Contacts / Relationships

• Interacts with vendors and internal functional groups

Quality Requirements

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office and Cleanroom production environment.
• May work extended hours during peak business cycles.
• Physical requirements include sitting for extended periods in an office environment and standing for extended periods in a cleanroom while fully gowned.
• Occasional travel may be required.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.