Aditi Consulting
Base pay range:
$55.00/hr – $59.38/hr.
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:
Interpretmu microbiological testing data, monitor, and maintain the sterility assurance program used in medical device manufacturing.
Apply standards and regulations to medical device microbiological and sterility assurance control programs for data interpretation, tactical planning, procedural implementation, 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 as needed.
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 and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, ISO 17664, CMDR, Medical Device Directive, and USP.
Interpret microbiological data to identify trends and issues requiring investigation.
Contribute to risk management activities, including PFMEA generation.
Coordinate scheduling, material allocation, and alignment of personnel to complete project assignments.
Create site procedures for microbiological testing and sampling in alignment with global procedures, validations, and application regulations.
Serve as microbiology representative on cross‑functional teams for transfer, NPI, and other projects, including supervision of contract resources.
Ensure all projects comply with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments 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 with workflow coordination and guidance in resolving problems or areas of concern.
Qualifications:
Bachelor’s degree or equivalent with 7+ years of experience; Master’s degree with 4+ years; Doctoral degree with 2+ years. 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 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 the environment and products in operations.
Knowledge of applicable microbiology standards, including AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, ISO 17664, and USP.
Ability to track milestones and manage projects.
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
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.
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 your 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 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; and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement are provided based on state or local law.
Seniority level Entry level
Employment type Contract
Job function Research, Analyst, and Information Technology
Industries Medical Equipment Manufacturing
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$55.00/hr – $59.38/hr.
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:
Interpretmu microbiological testing data, monitor, and maintain the sterility assurance program used in medical device manufacturing.
Apply standards and regulations to medical device microbiological and sterility assurance control programs for data interpretation, tactical planning, procedural implementation, 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 as needed.
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 and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, ISO 17664, CMDR, Medical Device Directive, and USP.
Interpret microbiological data to identify trends and issues requiring investigation.
Contribute to risk management activities, including PFMEA generation.
Coordinate scheduling, material allocation, and alignment of personnel to complete project assignments.
Create site procedures for microbiological testing and sampling in alignment with global procedures, validations, and application regulations.
Serve as microbiology representative on cross‑functional teams for transfer, NPI, and other projects, including supervision of contract resources.
Ensure all projects comply with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments 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 with workflow coordination and guidance in resolving problems or areas of concern.
Qualifications:
Bachelor’s degree or equivalent with 7+ years of experience; Master’s degree with 4+ years; Doctoral degree with 2+ years. 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 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 the environment and products in operations.
Knowledge of applicable microbiology standards, including AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, ISO 17664, and USP.
Ability to track milestones and manage projects.
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
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.
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 your 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 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; and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement are provided based on state or local law.
Seniority level Entry level
Employment type Contract
Job function Research, Analyst, and Information Technology
Industries Medical Equipment Manufacturing
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