MYS - Penang, Malaysia
Onsite
Engineer 2, Microbiology
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Microbiology Engineer II provides microbiological and contamination control support across manufacturing, validation, and quality operations within a medical device environment. The role is responsible for performing and overseeing routine and non-routine microbiological activities, including environmental monitoring, water and utility testing, sterilization and cleaning validations, and investigations, while ensuring compliance with regulatory, international, and internal quality standards. Working closely with cross-functional teams such as Quality, Manufacturing, Engineering, and external laboratories, the position supports product and process quality through risk assessments, change control, and microbiology-related investigations, while maintaining inspection readiness through strong technical expertise and adherence to established procedures.
What will you be doing?
The role is responsible for executing both routine and non-routine microbiological operations, including bioburden, endotoxin, sterility, water quality, and environmental monitoring. It involves analyzing and trending microbiological data to identify risks, supporting investigations and validations through specialized testing, and ensuring laboratory equipment is properly calibrated and maintained. The position also provides guidance to manufacturing and quality teams on effective contamination control practices.
In addition, the role focuses on validation and sterilization activities, such as developing and reviewing protocols for sterilization methods (e.g., EO, Gamma) and cleaning validations. It supports the qualification of cleanrooms, utilities, and water systems while conducting risk assessments to define validation requirements. The position evaluates sterilization performance and ensures all validation processes meet microbiological standards and regulatory expectations.
The role also leads and supports cross-functional projects, contributes microbiological expertise in product and process development, and coordinates deliverables for new initiatives or facility upgrades. It plays a key part in investigations, root cause analysis, CAPA, and change control activities, while supporting risk management practices. Additionally, it ensures compliance with regulatory standards through proper documentation, audit support, data integrity, and continuous improvement efforts in microbiology and contamination control.
What will you need to be successful?
The role is based in Batu Kawan, Penang and requires a Bachelor’s degree in Microbiology, Biotechnology, Biological Sciences, or a related field. Candidates with certifications such as ISO 13485 Internal Auditor, sterilization standards (ISO 11135/11137), cleanroom monitoring, GMP, or root cause analysis have an added advantage. The position typically requires 3–5 years of relevant experience in microbiology, contamination control, or quality engineering within a regulated environment, with hands-on exposure to environmental monitoring, cleanroom operations, microbiological testing, and validation activities. Strong knowledge of ISO standards, along with technical writing and data analysis skills, is essential.
From a competency perspective, the role demands strong technical microbiology expertise combined with problem-solving and analytical skills. The candidate should be detail-oriented, capable of working independently, and able to communicate effectively while collaborating across functions such as Quality, Manufacturing, and Engineering. A strong commitment to quality, compliance, and regulatory requirements is critical, along with the ability to manage documentation accurately and consistently.
The role involves working in cleanroom and controlled environments, requiring adherence to strict gowning and contamination control standards. It may include physical tasks such as accessing elevated areas for sampling, handling equipment, and supporting environmental monitoring activities. Occasional travel (less than 10%) to external sterilization sites is required, and the candidate must be flexible to work outside standard hours, including evenings or weekends, to support validation activities and project milestones.
You.Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account , Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
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