Job Title : Microbiologist II
Duration : 06+ month's contract
Location : Plano TX
MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
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.
· Facility and routine production microbiological support: Provide Facility Microbiological support including EM, BSC testing, DI systems and compressed air testing; Record review of routine microbiological test results; Technical support for facility issues in the areas of, environmental monitoring and microbiological methods; Conduct routine out of specification investigations; Develop and execute controlled access environment, deionized water, compressed and air qualifications; Assess manufacturing process changes for microbial impact; Complete environmental disturbance reports; and Complete annual controlled access environment reports.
· Technical sterilization and microbiological laboratory methods support: Routine release of manufactured product; Data analysis of sterilization processes; Writes protocols and reports for qualifications for sterilization and microbiological test methods; Conduct new product assessments for sterilization adoption or validation; Assist in the development of sterilization cycles; Develop laboratory test methods and train technicians as appropriate; Works with technicians in conducting these qualifications; Complete LAL sampling analysis; and Develop microbiological specifications for incoming components
· Documentation: Ensures correct documentation linkage flow for microbiologically related documents.
· Writes new or updates current microbiologically related documents.
· 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; and 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.
· Minimum 5 years With a Bachelor's degree, 5 years in a medical device/pharmaceutical, or related industry, with work experience in microbiology and/or sterilization and relevant microbiology laboratory experience.
· Minimum 2 years With a Master's degree, 2 years medical device/pharmaceutical or related industry, with experience in microbiology and/or sterilization and relevant microbiology laboratory experience.
· 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 timely manner.
· Strong organizational and follow-up skills, as well as attention to detail.
· Ability to travel approximately 5-10%, including internationally.