Boston Scientific Microbiologist III 

Costa Rica 

435704

Hybrid Roles:

About the Role:

Provide oversight of Microbiology Department for the sustaining operation, support projects requiring microbiology evaluation or testing. Under the direction of the Microbiology Manager, this position will serve as senior matter expert on microbiology, assuring the product meets documented requirements and that processes are controlled and providing support and guidance in the areas of cGMP, Regulatory, technical investigations.

Your Responsibilities Include:

· Strong knowledge of microbiology test methods, standards and regulations governing the quality system and microbiological topics.

· Review and assess from a microbiology context all changes that impact product or the cleanroom environment.

· Support new product development by participating as the microbiology functional team member and represent the Microbiology department on cross-functional project teams as required.

· Support Regulatory submissions by conducting review to ensure appropriate microbiology information is present in the submission.

· Review test reports from internal, external testing for compliance to BSC and external compliance requirements.

· Ensures that products are validated for bioburden and endotoxin testing and support the establishment of routine sampling plans.

· Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner.

· Provide technical guidance/troubleshooting in the event of Microbiology related issues.

· Act as Quality Engineer for Facilities related matters.

· Revise SOPs and support maintenance of product and environmental documentation.

· Support product bioburden alert limits and cleanroom air and surface alert and action limits periodical revision.

· Organizes and presents data/ information to influence decision making, primarily to internal audiences

What We’re Looking For:

• Degree in Microbiology, Biotecnology or related field.

• At least 3 years of experience in similar position.

• English Level desired: 80-89%.

Benefits • Life-Work Integration • Community • Career Growth