JOB DESCRIPTION

We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

We are currently looking for a Sterilization Quality Engineer I.

• The Sterilization Quality Engineer will be responsible for performing and coordinating all aspects of sterilization validation/requalification projects including process and product validation/requalification.
• Responsible for maintaining a safe working environment, promoting teamwork, and communicating effectively with all levels of personnel. This position reports directly to the Sterilization Validation Manager.

Main Responsibilities:

• Perform and coordinate all aspects of sterilization validation/requalification projects including process and product validation/requalification.
• Collaborate with various departments such as engineering, production, quality assurance, R&D, regulatory affairs, and technical service on new product introduction, product changes, and equipment modifications.
• Prepares validation/requalification protocols, summary reports, and other documentation required for regulatory submission and approval.
• Maintain accurate records and documentation related to validation/requalification activities.
• Provide training and guidance to other departments regarding sterilization validation/requalification procedures and requirements.
• Participate in external audits and inspections conducted by regulatory authorities or customers.
• Ensure compliance with cGMP, ISO 13485, ISO 11135, and other applicable regulations related to sterilization processes.
• Monitor and analyze data generated during validation/requalification studies to determine if sterilization cycles meet established parameters and criteria for effectiveness.
• Coordinate and execute periodic reviews of sterilization processes to identify potential improvements and optimize cycle times.
• Investigate sterilization cycle deviations and provide disposition
• Assist with Failure Investigations, root cause analysis and dispositions for Management approval.
• Revise and/or develop SOPs to support sterilization programs
• Perform supplier and internal audits as needed
• Perform tracking and trending of sterilization metrics

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Microbiology, or equivalent.
• Preferred minimum of two years of experience in a related field.
• Proven track record of successfully managing complex projects and delivering results in a timely manner.
• Excellent communication skills both written and verbal.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Strong organizational skills and attention to detail.
• Knowledge of Good Manufacturing Practices (cGMP), International Organization for Standardization (ISO) standards, and other relevant regulations.
• Familiarity with medical device manufacturing and sterilization processes.
• Competency in Microsoft Office Suite applications.
• Fluent English language proficiency is essential. Spanish language skill is desirable.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

• Perform and coordinate all aspects of sterilization validation/requalification projects including process and product validation/requalification.
• Collaborate with various departments such as engineering, production, quality assurance, R&D, regulatory affairs, and technical service on new product introduction, product changes, and equipment modifications.
• Prepares validation/requalification protocols, summary reports, and other documentation required for regulatory submission and approval.
• Maintain accurate records and documentation related to validation/requalification activities.
• Provide training and guidance to other departments regarding sterilization validation/requalification procedures and requirements.
• Participate in external audits and inspections conducted by regulatory authorities or customers.
• Ensure compliance with cGMP, ISO 13485, ISO 11135, and other applicable regulations related to sterilization processes.
• Monitor and analyze data generated during validation/requalification studies to determine if sterilization cycles meet established parameters and criteria for effectiveness.
• Coordinate and execute periodic reviews of sterilization processes to identify potential improvements and optimize cycle times.
• Investigate sterilization cycle deviations and provide disposition
• Assist with Failure Investigations, root cause analysis and dispositions for Management approval.
• Revise and/or develop SOPs to support sterilization programs
• Perform supplier and internal audits as needed
• Perform tracking and trending of sterilization metric