**Work mode**:Hybrid**Onsite Location(s)**:Cartago, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our compromise.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.**About the Role**:
- BSC Cartago West is a greenfield Site requiring the creation/implementation of a robust quality system in compliance with applicable quality system regulations. This position will have the unique opportunity to be part of a cross functional team to establish, develop, and maintain procedures related to Microbiology and Sterilization (including controlled environments) to meet regulatory requirements, corporate policies, internal policies, and business needs to support the successful launch of transfer products. Also, this is a key role to prepare the manufacturing site to host successful inspections by competent authorities like FDA and external audits by NB.**Your Responsibilities Include**:
- Supports the Controlled Environment Rooms and critical systems (OFA & HPW) qualification processes.
- Establish and maintain the monitoring program of controlled environments in the new Cartago West site.
- Establish and maintain the finished goods microbiological testing program.
- Lead the establishment of Microbiology Lab procedures in alignment with corporate requirements, as well as international regulations such as QSR/GMPs and ISO 13485.
- Lead tasks related to Microbiology Investigation Systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system.
- Oversee the validation of the Microbiology Lab´s new equipment.
- Review test results and reports.
- May supervise the Microbiology Lab´s technical personnel.
- Create budgets for the Microbiology Lab.
- Coordinate the purchase of the equipment needed for the laboratory´s operation.
- Participate as internal auditor in ISO 13485 and GRS/GMPS.
- Establish and maintain the product testing program for bioburden and LAL
**What We're Looking For**:
- Licenciature degree in Biotechnology, Microbiology, Biology, or Related Field.
- English Level desired: B2:(80-89%).
- Desired knowledge: Sterilization of medical devices, Microbiology Control for Cleanrooms, Microbiology testing validation and Controlled Environment Qualification.
- At least 2 years of experience in similar position.
**Requisition ID**:577986- **Benefits - Life-Work Integration - Community - Career Growth**
- At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.**Job Segment**:Manufacturing Engineer, Compliance, Medical Device, Internal Audit, Scientific, Engineering, Legal, Finance, Healthcare