11 months contract
 

Job Description and Role Purpose:

• Conduct studies to establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols

• Identify basic testing approaches to perform microbiological testing, investigations, isolation and identification

• Develop protocols, reports, and methods in collaboration with inter-departmental teams

• Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing

• Participate in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval

• Collect samples for studies

• Create and develop validation plans for laboratory equipment and methods

• Investigate and perform lab corrective and preventative actions (CAPA) testing

• Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes

• May train, coach, and guide lower-level employees on new procedures, assess work techniques and provide feedback on procedures

• Other incidental duties assigned by Leadership

Requirements

Bachelor's degree in Microbiology, or Biotechnology

1 year of experience in the field

Experience in the medical device industry

Availability to work overtime if needed

Intermediate English (60-70%)

Basic documentation, communication and interpersonal relationship skills

Strict attention to detail

Ability to build stable working relationships internally