- Location
- MYS - Penang, Malaysia
- Type
- Full-time
- Department
- Engineering
- Experience
- 3+ years
- Closing date
- Today
- Source
- Workday
Description
Microbiology Engineer 2
Life Unlimited. At Smith+Nephew we craft and manufacture technology that takes the limits off living.
Microbiology Engineer II supports microbiological and contamination control activities across manufacturing, quality, and validation operations in a medical device environment. The role is responsible for environmental monitoring, utility testing, sterilization and cleaning validations, investigations, and ensuring compliance with regulatory and quality requirements.
The position works closely with cross-functional teams and external laboratories to maintain effective microbiological controls, support product quality, lead investigations, contribute to risk assessments and change controls, and ensure inspection readiness.
What will you be doing?
Routine & Non-Routine Microbiological Operations (30%)
Conduct microbiological testing, environmental monitoring, and data analysis to identify contamination risks, support investigations, and maintain laboratory compliance.Validation & Sterilization Activities (27%)
Support sterilization, cleaning, and process validations while ensuring microbiological controls, risk assessments, and regulatory compliance.Project Leadership & Cross-Functional Support (20%)
Lead and support contamination control, process improvement, and product transfer projects by providing microbiological expertise and ensuring project compliance.Investigations, Risk Management & Change Control (10%)
Drive microbiology-related investigations, root cause analyses, CAPA implementation, and risk assessments to maintain product and process quality.Compliance, Documentation & Audit Support (13%)
Maintain compliance with regulatory and quality standards through documentation management, audit support, data integrity, and continuous improvement initiatives.Health, Safety & Environment (HSE)
Comply with HSE, sustainability, and energy policies, promote a safe workplace, prevent environmental impact, and report incidents and improvement opportunities.
What will you need to be successful?
The ideal candidate holds a Bachelor’s degree in Microbiology, Biotechnology, Biological Sciences, or a related field, with 3–5 years of experience in microbiology, contamination control, or quality engineering within a regulated medical device, pharmaceutical, or manufacturing environment. Experience in environmental monitoring, cleanroom operations, microbiological testing, process validations, and knowledge of standards such as ISO 13485, ISO 11135, ISO 11137, and ISO 14644 is essential. Professional certifications in auditing, sterilization, GMP, or root cause analysis are an added advantage.
The role requires strong technical microbiology expertise, analytical and problem-solving skills, technical writing capability, and the ability to collaborate effectively across functions while maintaining a strong focus on quality and regulatory compliance. The candidate must be comfortable working in cleanroom environments, performing sampling and monitoring activities, supporting validation work outside normal business hours when required, and traveling occasionally (<10%) to external sterilization sites for validation or audit activities.
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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