Senior R&D Microbiologist

SR R&D MicrobiologistJob Description

We seek a Sr R&D Microbiologist who thrives in a fast-paced environment and is relentless about ensuring project completion and compliance with regulations and expectations. This role focuses on microbial compliance of our products according to relevant regulatory requirements and standards for medical devices. Responsibilities include overseeing and ensuring sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities. You will also lead root cause analysis, technical documentation, and cross-functional collaboration to develop best practices.

MUST HAVE

Review of validation files for compliance

Performing sterility release review

Performing validations and re-qualifications

Bachelors degree in Microbiology or a related discipline

6 years experience as a Microbiologist in a regulated industry

Competency in troubleshooting, correction of NC and root cause analysis

Leads NC and CAPA generation and resolution

Applying cGLP to all laboratory activities

Subject matter expertise in internal & external regulatory requirements

Ensuring compliance of new products to sterile and non-sterile standards

Providing Technical Assessment for Risk Assessment

Mentoring and training team members

Work Site

This is a fully on-site position in Cary, Illinois.

Work Environment

Brand new R&D lab. Will work with the team until the team is fully built. Reports to the department head. 1st shift M-F (hours vary).

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About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.