- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Curious learners.
People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what’s next.
What You Will Do
The Microbiologist will be responsible of conducting microbiological testing using qualified laboratory equipment and procedures applicable to the department and reviewing and approving microbiological testing data ensuring compliance to the applicable methods and regulatory standard requirements.
- Comply with cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the microbiology and endpoint analysis of medical devices;
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products;
- Lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ);
- Be the subject matter expert and point of contact for suppliers for new process development, quality issues and process improvements for assigned projects;
- Support product transfers;
- Review/approve product and process change control documentation and specifications;
- Review/approve nonconforming material and system documentation;
- Act as mentor to others;
- As necessary conduct laboratory testing such as: Bioburden, Microorganism Identification, Growth Promotion, and Endotoxin, using qualified laboratory equipment and following the applicable written procedures;
- Conduct environmental sampling to the manufacturing-controlled areas to support Monitoring Program;
- Prepare reports related to microbiological analysis, CA Monitoring Program, and monthly metrics;
- Review and approve data related to the microbiological testing ensuring compliance to requirements set forth in applicable standards and test methods;
- Train new personnel and existing on CA controls and ensure that the applicable requirements are;
- Train new personnel and existing on microbiology testing and proper testing techniques;
- Assure the laboratory equipment is qualified, calibrated and within PM (Preventive Maintenance) program;
- Conduct laboratory testing method qualification and laboratory equipment validations;
- Provide support during audits (FDA, TUV or other related);
- Review and approve reports of Biological Indicators or sterility analysis;
- Provide support to the sterilization processes validation;
- Review of Biocompatibility documents;
- Coordinate and manage the testing conducted by external laboratories according to procedures;
- May be required to perform other duties as required to the operations and according to his/her abilities and skills;
- Comply with Health and Occupational Safety politics (EHS).
What You Will Need
- B.S. in Microbiology or Biology, or related discipline from accredited university;
- At least 3+ years of experience with method validation experience preferable in medical devices;
- Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures;
- Demonstrated knowledge of the fundamentals of sterilization process;
- Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies;
- Ability to complete complex tasks using creativity, personal experience and good judgment;
- Experience conducting laboratory testing;
- Knowledge in identification of microorganisms;
- Knowledge in microbiology lab equipment installation and operational qualification validations;
- Demonstrated ability to solve problems, troubleshooting, and organize priorities;
- Demonstrated interpersonal communication skills;
- A positive, energetic team player, and an advocate for product excellence and quality;
- Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met;
- Demonstrated ability to technically mentoring junior engineers and scientists;
- Demonstrated ability to sustain exceptional performance and / or have more experience in a large role;
- Strong analytical skills;
- Strong laboratory aseptic techniques;
- Effective interpersonal skills;
- Microbiology and sterility testing execution skills;
- Communicate (read, write, and understand) In English and Spanish.
Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.
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