Microbiologist IV

Description:


Position Summary
*** is seeking an experienced Senior Microbiologist to provide technical support for contract-manufactured devices, acquisition activities, new product development projects, microbiological risk assessments, and quality system activities across the organization.
This position will serve as a microbiology subject matter expert (SME), partnering with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external business partners to evaluate microbiological risks, support investigations, assess product and process changes, and ensure compliance with applicable quality system requirements.
The successful candidate will operate in a highly collaborative environment, providing scientific expertise and risk-based decision-making to support product quality, patient safety, and regulatory compliance.
Key Responsibilities
Serve as a microbiology SME supporting contract manufactured devices and external manufacturing partners.
Support acquisition due diligence activities, product integration efforts, and manufacturing transfer initiatives.
Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes.
Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation.
Evaluate microbiological impact associated with product, process, material, supplier, and facility changes.
Support investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertise.
Partner with cross-functional teams to assess microbiological considerations related to manufacturing, design changes, commercialization activities, and supplier controls.
Provide microbiology support for new product development projects and product lifecycle management activities.
Participate in audits, inspections, and regulatory readiness activities as needed.
Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements.
Communicate microbiological risks, recommendations, and technical rationale to stakeholders across multiple functions and geographic regions.



Minimum Qualifications
Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.
Minimum of five (5) years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industry.
Experience performing scientific evaluations and technical risk assessments.
Strong technical writing and documentation skills.
Ability to independently manage multiple projects and priorities.
Strong communication and stakeholder management skills.



Preferred Qualifications
Medical device industry experience strongly preferred.
Experience supporting contract manufactured products or external manufacturing partners.
Experience supporting acquisitions, manufacturing transfers, or product transfer activities.
Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.
Experience supporting CAPA, investigations, nonconformance management, and change management activities.
Familiarity with FDA regulations, ISO 13485, and other applicable global quality system requirements.
Experience working in cross-functional and global project teams.
Experience presenting technical recommendations to leadership and project teams.
Desired Competencies
Strong scientific and technical problem-solving skills.
Risk-based decision-making capability.
Ability to influence stakeholders through scientific rationale.
Excellent written and verbal communication skills.
Strong organizational and project management abilities.
Ability to work effectively across multiple functions, sites, and geographic regions.
Travel
Approximately 10-20% travel may be required to support site activities, audits, acquisitions, manufacturing transfers, project teams, and business needs.