Senior Microbiologist

REQ Solutions Pvt Ltd; Saint Paul (MN); Híbrido; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

REQ Solutions Pvt Ltd in Minnesota seeks an experienced Sr. Microbiologist to provide technical support for contract manufactured devices, risk assessments, and quality system activities across the organization.

The role demands collaboration with cross-functional teams to ensure product quality, regulatory compliance, and patient safety. You will author MBERs, evaluate microbiological impact of changes, and mentor junior staff.

Formación

• Bachelor's degree in Microbiology or related field.
• Minimum 5 years in microbiology, quality, manufacturing, or related regulated function.
• Strong technical writing and documentation skills.
• Ability to manage multiple projects and priorities.

Responsabilidades

• Provide technical support for contract manufactured devices and external manufacturing partners.
• Perform microbiological risk assessments for products, materials, processes, facilities, and supplier changes.
• Author and review Microbiology Evaluation Reports (MBERs) and supporting docs.
• Support investigations, CAPAs, nonconformances, and regulatory readiness activities.
• Communicate microbiological risks and recommendations to stakeholders across regions.

Conocimientos

Technical writing

Risk assessment

Cross-functional collaboration

Stakeholder management

Regulatory knowledge

Educación

Bachelor's degree in Microbiology

Descripción del empleo

Hybrid Role

Responsibilities:

• Seeking an experienced Sr. 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.
• Operate in a highly collaborative environment, providing scientific expertise and risk-based decision making to support product quality, patient safety, and regulatory compliance.
• 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.

Education/Experience:

• 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:

• 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.
• Ability to work effectively across multiple functions, sites, and geographic regions.