Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes."

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Scientist-Microbiology and Sterilization.

Purpose:

The Analyst, R&D/Scientific Quality / Scientist II, Microbiological Quality & Sterility Assurance (MQSA) position is responsible for individual contributor execution of end-to-end implementation of contamination control and sterility assurance policies and strategies for Medtech Costa Rica and will assure that local programs are aligned with the overall Microbiological Quality & Sterility Assurance policies. This role will support the MQSA responsibilities in Costa Rica, Grecia Alajuela.

The Analyst, R&D/Scientific Quality / Scientist II will serve as a technical contributor in the areas of microbiological quality, contamination control, cleaning, and sterilization. They will execute activities to support product manufacturing activities, product development, lifecycle management, and event resolution. They will contribute through the application of technical knowledge and expertise in contamination control, microbiological quality, aseptic processing, and sterilization processing. This position is responsible for compliance to applicable Quality Regulations and standards.

This is not meant as an all-inclusive list but top-level list of duties that this person generally completes. It is also understood that an associate may receive special projects outside of this list.

You will be responsible for:

Under supervision and in accordance with all applicable federal, state and local laws/regulations and Medtech, procedures and guidelines, this position:

• R&D
  • Provide input for the following for increasing complexity projects:
    • Design for cleanability
    • Design for decontamination
    • Design for sterilizability
  • Drive selection of sterilization modality, validation approaches and validation of the sterilization process.
  • Generate sterilization product adoptions and validation documents. 
  • Support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing, to include such activities as in participating in development of new products
  • Provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally
• Plan
  • Support the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
• Source
  • Provide sterility assurance and microbiological quality support for procurement activities that relate to sterile, non-sterile, or products requiring microbiological control that are externally manufactured
  • Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint
  • Provide input for the design of critical utility systems and controlled environments to ensure that sterility assurance and microbiological quality requirements are maintained.
  • Provide sterility assurance and microbiological quality support for audits of external vendors. 
• Make –
  • Provide sterility assurance and microbiological quality control support to strategic MAKE initiatives.
  • Support and execute sterile release of routine sterilization processes.
  • Provide input into process risk assessments related to product cleanliness and sterility assurance 
  • Perform investigations for non-conformance/CAPA pertaining to product cleanliness and sterility assurance
  • Work with internal and external laboratories to support sterility assurance testing requirements.  Assure implementation of laboratory testing requirements for cleanliness and sterility assurance.
  • Plan and execute product and process monitoring activities, including reporting of results in accordance with defined requirements.
  • Provide support during internal and external audits of the MQSA organization.
  • Evaluate changes to process and/or product to ensure that sterility assurance and microbiological quality requirements are maintained.
• Internal Influencing
  • Interacts with business leaders to ensure objectives and project prioritization meet business needs.  Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities. 
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• University Bachelor Degree with Microbiology, Biology, Engineering or related discipline life science discipline.
• A minimum of 2 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required. 
• Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.
• Fluent in Spanish and English.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES

• Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
• Basic knowledge of associated regulations such as US FDA (QSR) regulations and ISO 13485
• Basic knowledge in competent authority regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred
• Good interpersonal and organizational skills.
• Must be able to effectively manage multiple tasks and projects.
• Comfortable to work with cross functional teams.
• Excellent communication skills - Written and Oral.
• Strong attention to detail.