Senior Microbiologist – CMP remediation

Aditi Consulting; Princeton (NJ); On-site; USD 75,768 - 81,801; Full time

Benefits offered by this job

Medical benefits

Dental benefits

401(k) plan participation

Job summary

A leading medical device company in New Jersey is seeking a senior microbiology professional to ensure compliance with sterility assurance programs and quality principles. The ideal candidate will have at least a Bachelor’s degree in Microbiology and extensive experience in microbial testing and project management within regulated environments. Responsibilities include data analysis, protocol generation, and maintaining compliance with FDA and quality standards. Competitive hourly pay and contract-based employment with comprehensive benefits are offered.

Qualifications

• 7+ years of microbiology experience for Bachelor’s degree candidates.
• Excellent communication skills and results-oriented approach.
• Experience creating and changing microbiological procedures.

Responsibilities

• Interpret microbiological testing data and maintain sterility programs.
• Generate and execute microbial method validation protocols.
• Interpret microbiological data for trend identification.

Skills

Microbial test method validations

Organizational skills

Technical writing

Quality principles

Project management

Education

Bachelor’s degree in Microbiology or related

Tools

Microbiological standards (AAMI ST72, ISO 11737)

Job description

Summary

The candidate must be a senior‑level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.

Responsibilities

• Work with corporate and sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance program used in medical device manufacturing.
• Interpret and apply standards and regulations to medical device microbiological and sterility assurance control programs for data interpretation, tactical planning, implementing procedures, and remediation projects.
• 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 appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, and USP.
• Interpret microbiological data to identify trends and issues that require investigation.
• Contribute to risk management activities, including PFMEA generation.
• Coordinate scheduling, material allocation, and personnel alignment to successfully complete project assignments.
• Create site procedures for microbiological testing and sampling in alignment with global procedures, validations, and compliance with application regulations.
• Serve as Microbiology representative on cross‑functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Support and address comments and suggestions associated with 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 with coordinating workflow and providing guidance in the resolution of problems or areas of concern.

Qualifications

• Bachelor’s degree or equivalent with 7+ years of experience, Master’s degree with 4+ years of experience, Doctoral degree with 2+ years of experience; preferably a Master of Science in Microbiology or a similar discipline.
• Excellent organizational and communication skills.
• Results oriented with a strong focus on quality principles.
• Excellent technical writing skills with an understanding of good documentation practice.
• Experience conducting microbial test method validations and managing projects independently.
• Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
• Working knowledge of applicable microbiology standards, including AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, and USP.
• Ability to track milestones and manage projects.
• Working knowledge of applicable regulations and their interpretation within industry.

Desired Skills

• 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 preference for experience in controlled environment monitoring, water system monitoring, compressed air monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management, and reprocessible device cleaning and sterilization validation.

Pay Transparency

The typical base pay for this role across the U.S. is $55.00 - $59.38/hr. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages, which may include medical, dental, and vision benefits, health savings accounts, paid time off, bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement are provided based on state or local law.

Consent to Communication and Use of AI Technology

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Job Details

Seniority level: Entry level
Employment type: Contract
Job function: Research, Analyst, and Information Technology
Industries: Medical Equipment Manufacturing