Engineer 2, Microbiology job opportunity at Smith+Nephew.

Home Jobs In Malaysia Tag: Microbiology Engineer 2, Microbiology position at Smith+Nephew


DatePosted 5 Days Ago bot
Smith+Nephew Engineer 2, Microbiology
Experience: 5-years
Pattern: full-time
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Microbiology

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loacation MYS - Penang, Malaysia
loacation MYS - Penang....Malaysia

Engineer 2, Microbiology    Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.    The Microbiology Engineer II supports microbiological and contamination control activities across manufacturing, validation, and quality operations within a medical device environment, overseeing routine and non-routine work such as environmental monitoring, water and utility testing, sterilisation and cleaning validations, and microbiological investigations while ensuring compliance with regulatory, international, and internal quality standards. The role partners closely with Quality, Manufacturing, Engineering, and external laboratories to maintain robust microbiological controls, supports product and process quality through cross-functional projects, contributes to risk assessments and change management, leads microbiology-related investigations, and ensures inspection readiness through strong technical judgment and adherence to procedures.   What will you be doing?   Routine & Non-Routine Microbiological Operations Conduct routine and ad-hoc microbiological testing, trend and interpret data to identify contamination risks, maintain lab equipment readiness, and provide contamination control guidance to manufacturing and quality teams.   Validation & Sterilisation Activities Plan and execute sterilisation, cleaning, and environmental validations, perform microbiology risk assessments, evaluate cycle performance and inactivation data, and ensure validation activities meet microbiological and regulatory requirements.   Project Leadership & Cross-Functional Support Lead and support contamination control and process improvement projects, provide microbiology input to design and development activities, coordinate cross-functional deliverables, and ensure projects comply with quality and regulatory expectations.   Investigations, Risk Management & Change Control Lead microbiology-related investigations, perform root cause analysis and CAPAs, assess microbiological impact of changes, support risk assessments, and ensure timely closure and effectiveness of actions. Compliance, Documentation & Audit Support Ensure microbiology activities comply with ISO, regulatory, and internal quality requirements, maintain accurate technical documentation and data integrity, support audits and inspections as the SME, and drive continuous improvement in lab compliance, efficiency, and contamination control.   What will you need to be successful? This role is based in Batu Kawan, Penang, and requires a Bachelor’s degree in Microbiology, Biotechnology, Biological Sciences, or a related field. Candidates with added certifications such as ISO 13485 Internal Auditor, EO or Radiation Sterilization (ISO 11135 / ISO 11137), Cleanroom or Environmental Monitoring, GMP, or Root Cause Analysis will have a strong advantage, as these directly support compliance and sterilisation requirements in a regulated manufacturing environment. The ideal candidate brings 3–5 years of experience in microbiology, contamination control, or quality engineering within medical device, pharmaceutical, or similarly regulated industries, with hands-on exposure to environmental monitoring programmes, cleanroom operations, microbiological testing, and support for cleaning, sterilisation, or process validations (including protocol execution and reporting). A solid understanding of ISO 13485, ISO 11135, ISO 11137, ISO 14644, and relevant regulatory requirements, along with strong technical writing and data analysis skills, is essential. The role requires strong technical microbiology expertise, problem-solving and analytical capability, attention to detail, and the ability to work independently while collaborating effectively across functions with a strong commitment to quality and compliance. Physically, the candidate must be comfortable working in cleanroom and controlled environments, performing sampling activities (including accessing elevated areas and handling moderate loads), travelling occasionally to external sterilisation sites, and supporting activities outside normal business hours when needed. Travel is expected to be minimal (under 10%). 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 Stay connected by joining our Talent Community . We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.    Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.  

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