The Sr. Microbiologist position will be working with corporate and various sites interpreting microbiological testing data, monitoring, and providing remediation support for 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 programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects. 

Location Requirements: Mansfield, Princeton, or Salt Lake City or remote for right candidate. Candidates closely located to Mass, NJ, or Salt Lake City will be preferred but not required.

Required Skills:

• General Microbiologist - must have Medical Device Experience
• Medical Device understanding from product design to sterilization requirements
• Clean room practice/cGMP and laboratory/GLP environments Quality experience - risk assessment, CAPA, understanding end product start to finish
• Change control, non-conformance and CAPA support as a microbiology and sterility assurance subject matter expert.
• Results oriented with a strong focus on quality principles
• Minimum required education and experience: 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

ESSENTIAL DUTIES AND RESPONSIBILITIES

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
• 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 in order to identify trends and issues that require investigation and/or remediation.
• Contribute to risk management activities including PFMEA generation and gap assessments.
• Scheduling coordination, material allocation and alignment of personnel in order 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.
• 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.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.