Sr Microbiologist-Sterilization Supervisor

Job Description

Sr. Microbiologist-Sterilization Supervisor | Medtronic

The Tone:
This is a full-time role at Medtronic, located in Singapore. Medtronic is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for patients worldwide. This role is crucial for ensuring the safety and quality of medical technologies manufactured in Singapore, through expert oversight of sterilization processes and microbiological controls. The work directly contributes to patient safety and regulatory compliance, supporting the company’s mission to improve lives.

The TL;DR
• Role: Full Time
• Type: Full Time
• Location: In-person Singapore
• Team: Leads the Sterilization and Microbiological Laboratory team, which is part of the Sterilization and Microbiology function.
• Mission: Leads the Sterilization and Microbiological Laboratory team, ensuring timely and accurate testing, sterilization services, and technical support for manufacturing operations.

What You’ll Actually Do
• Lead the Sterilization and Microbiological Laboratory team to ensure timely execution of testing, monitoring, and sterilization activities that support production schedules and quality objectives.
• Oversee microbiological analyses of raw materials, in-process materials, release samples, stability samples, and other materials in accordance with established procedures and specifications.
• Direct sterilization operations and related quality activities to ensure compliance with applicable regulatory, quality system, and operational requirements.
• Review and evaluate microbiological and sterilization data, interpret results, identify trends, and implement corrective and preventive actions when required.
• Develop, validate, implement, and maintain controlled environment and microbiological testing methods to support manufacturing and quality programs.

The Must-Haves
• Background: Bachelor’s degree in microbiology, sterilization, laboratory operations, quality, or a related regulated manufacturing environment.
• Experience: Minimum of 3 years of relevant experience with a Bachelor’s degree, or 1 year with an advanced degree; includes leading or supervising employees, performing or overseeing microbiological testing, and investigating quality issues in a regulated environment.
• Skills: Microbiological testing, Sterilization operations oversight, Data review and interpretation, Method development and validation, Quality investigation and CAPA.
• Bonus: Experience with Ethylene Oxide (EO) sterilization processes, validation, monitoring, and requalification; experience in medical device or other highly regulated industries; knowledge of contamination control programs and environmental monitoring systems; experience with methodology transfer, validation, and implementation of new analytical techniques; experience using data analysis and continuous improvement methodologies.