Microbiologist I

The Opportunity

This is the entry level exempt position for Microbiology. This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device. This position is at the Plymouth location and works typical business hours in office.

What You'll Work On

• Provides Microbiological Support: Record review of routine microbiological test results; Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods; Conduct routine out of specification investigations; Perform data analysis of sterilization processes; Develop and execute controlled access environment, deionized water and compressed air qualifications; Assess manufacturing process changes for microbial impact.
• Documentation: Ensures correct documentation linkage flow for microbiologically related documents; Writes new or updates current microbiologically related documents; Complete environmental disturbance reports; Complete LAL risk assessments; Complete annual controlled access environment reports.
• Maintains understanding of applicable standards and applies them to qualifications and test methods.
• Writes protocols and reports for qualifications for sterilization and microbiological test methods: Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.
• Technical Training: Provides training to laboratory technicians on new equipment or new test procedures and provides training in the areas of sterilization validation and sterilization processes.
• Other Projects as Directed by Department Manager.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelors Degree (± 16 years) - Microbiology or related science or an equivalent combination of education and work experience.
• Minimum 2 years medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled).
• Experience in Microbiology and/or sterilization.
• Person in this position demonstrates professional skills with excellent written communication.
• Able to work with minimal supervision and ability to maintain regular and predictable attendance.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5-10%, including internationally.

Pay

The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.