• 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

• 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
• 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
• Ability to track milestones and manage projects

Working knowledge of applicable regulations and their interpretation within industry

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position 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

• 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 (phone number removed), and USP

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 (including auto telephone dialing systems or automatic text messaging systems), 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

• Payrate: $55.00 - $59.38/hr
• 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

Packages 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 provided based on state or local law