Aditi Consulting
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 By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated, pre‑recorded, AI‑assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human‑based decision‑making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy.
Job Details Seniority level: Entry level Employment type: Contract Job function: Research, Analyst, and Information Technology Industries: Medical Equipment Manufacturing
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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 By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated, pre‑recorded, AI‑assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human‑based decision‑making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy.
Job Details Seniority level: Entry level Employment type: Contract Job function: Research, Analyst, and Information Technology Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr