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Aditi Consulting · 9 hours ago

Senior Microbiologist – CM/OEM

Princeton, NJ

Contract

Onsite

Senior Level

$55/hr - $59.38/hr

7+ years exp

Aditi Consulting is seeking a Senior Microbiologist with advanced knowledge and experience in microbiological testing and sterility assurance in a medical device manufacturing environment. The role involves interpreting microbiological data, managing testing processes, ensuring compliance with regulations, and contributing to risk management activities.

AppsConsultingInformation TechnologySoftware Engineering

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Responsibilities associated with this Sr. Microbiologist, CM/OEM contractor include working with corporate and sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance program used in medical device manufacturing

The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects

Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation

Design experimental plans to address specific microbiological quality issues as needed

Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting

Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including, but not limited to, 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

Scheduling coordination, material allocation and alignment of personnel to successfully complete project assignments

Create site procedures for microbiological testing and sampling in alignment with global procedures, validations and in 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

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

Qualification

MicrobiologyCGMPMicrobial method validationMicrobial monitoringRisk managementMicrobiology standardsProject managementTechnical writingCommunication skillsOrganizational skills

Required

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

Bachelor's, or preferably Master of Science degree, in Microbiology or similar discipline

Demonstrates 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, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 176647, and USP

Ability to track milestones and manage projects

Working knowledge of applicable regulations and their interpretation within industry

Preferred

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

Work 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 is strongly preferred

Benefits

Medical

Dental

Vision benefits

Health savings accounts with qualified medical plan enrollment

10 paid days off

3 days paid 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

Accommodations and reimbursement for work travel

Discretionary performance or recognition bonus

Sick leave

Mobile phone reimbursement

Company

Aditi Consulting

Glassdoor4.2

Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.

Founded in 1994

Bellevue, Washington, USA

1001-5000 employees

https://aditiconsulting.com

H1B Sponsorship

Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (38)

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2020 (30)