SRG, the leader in the Life Sciences human capital industry, is looking for a Sr. Microbiologist, CM/OEM Contractor to join our team supporting medical device manufacturing.

Location: Princeton, NJ
Contract: 12 months

Overview

The Sr. Microbiologist, CM/OEM Contractor will work closely with corporate and site teams to interpret microbiological testing data, monitor, and maintain the sterility assurance program for medical device manufacturing. This role requires advanced knowledge of microbiological and sterility assurance control programs, including interpreting and applying standards and regulations, tactical planning, implementing procedures, and leading remediation projects. The position reports into Global Laboratories, Microbiology, and Sterility Assurance, collaborating with the Princeton site and contract manufacturers.

Qualifications & Skills

• Bachelor's degree or equivalent with 7+ years of experience, Master's degree with 4+ years, or Doctoral degree with 2+ years in Microbiology or a related discipline (Master of Science preferred).
• Senior-level professional/team player with advanced knowledge and experience.
• Experience as a Microbiologist in one or more of the following areas, with subject matter expertise in at least one:
  • Controlled environment monitoring
  • Water system monitoring
  • Bacterial endotoxin test method validation and monitoring
  • Bioburden test method validation and monitoring
  • Radiation sterilization validation and dose audit management
  • Ethylene oxide sterilization validation and requalification
  • Reprocessible device cleaning and sterilization validation
• Strong understanding of clean room practice/cGMP and laboratory/GLP environments.
• Knowledge of risk management as it relates to microbial monitoring and sterility assurance.
• Excellent organizational and communication skills.
• Results-oriented with a strong focus on quality principles.
• Excellent technical writing skills and understanding of good documentation practice.
• Experience conducting microbial test method validations and managing projects independently.
• Experience creating and changing procedures for microbiological monitoring of environments and products.
• Working knowledge of applicable microbiology standards and regulations, including but not limited to:
  • FDA, ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, USP.
• Ability to track milestones and manage projects.
• Ability to interpret and apply regulations within the industry.

Responsibilities

• Generate and execute microbial method validation protocols and reports, including writing, routing, and approval of summary documentation.
• Design experimental plans to address specific microbiological quality issues.
• Manage sample/testing processing with onsite and third-party labs, ensuring timely testing and result reporting.
• Ensure compliance of microbiology procedures, validations, and records with all company policies, procedures, and applicable regulations.
• Interpret microbiological data to identify trends and issues requiring investigation.
• Contribute to risk management activities, including PFMEA generation.
• Coordinate scheduling, material allocation, and personnel alignment to complete project assignments.
• Create site procedures for microbiological testing and sampling in alignment with global procedures and regulations.
• Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects, including supervision of contract resources.
• Work in controlled environment monitoring, water system monitoring, compressed air monitoring, bacterial endotoxin and bioburden test method validation and monitoring, ethylene oxide and radiation sterilization, dose audit management, and reprocessible device cleaning and sterilization validation.
• Ensure all projects comply with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable requirements.
• Support and address comments and suggestions related to sterilization and microbiological test method validations and monitoring procedures.
• Provide change control, non-conformance, and CAPA support as a microbiology and sterility assurance subject matter expert.
• Support the department manager in coordinating workflow and providing guidance for problem resolution.

Only candidates selected to move forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.