Senior Sterilization

Senior Sterilization (Microbiology)

Join a transformative MedTech player, poised to expand in Malaysia and shape the region's healthcare ecosystem.

We are looking for an experienced Senior Sterilization (Microbiology), on behalf of our client, a well-established, high-impact organisation in the Medtech sector. The company is entering a strategic growth phase and requires a professional with expertise in ensuring sterilization processes comply with FDA, PMDA, ISO 11135 and ISO 13485 requirements, leading validation activities, driving process improvements, mentoring junior team members, and collaborating with global teams to standardize sterilization practices across the organization.

About this role:

As a Senior Sterilization (Microbiology), you will be responsible for leading and validating sterilization processes at our client's manufacturing facility, ensuring full compliance with FDA regulations and ISO standards (ISO 11135, ISO You will serve as the subject matter expert for microbiological controls, maintain QMS documentation, and collaborate with global teams to standardize and enhance sterilization practices. You will also oversee risk assessments, equipment performance, and CAPA investigations, while mentoring junior team members to strengthen technical and regulatory capability.

Your responsibilities may include:

·       Leading sterilization processes, including validations, and ensuring full compliance with global FDA regulations and quality ISO standards (e.g. ISO 11135, ISO 13485, FDA).

·       Serving as lead subject matter expert (SME) to validate and implement sterilization processes and microbiological controls.

·       Navigating Quality Management Systems (QMS) to create and maintain controlled documentation.

·       Collaborating with cross-functional and global teams to ensure standardization of and adherence to sterilization protocols and best practices.

·       Maintaining sterilization risk assessments (e.g. FMEAs) and microbiological control documentation.

·       Overseeing the maintenance, calibration and performance of sterilization equipment.

·       Providing root cause analysis and corrective/preventive actions (CAPA) for sterilization-related nonconformances.

·       Supporting and training junior engineers on EO processes, microbiological testing and regulatory compliance.

·       Travel internationally for 6- 12 months to receive training, learn end-to-end processes, and gain exposure to global best practices.

Essential skills, qualification and experience:

• Minimum of 4 years of experience in medical device or pharmaceutical industry, preferably within Sterility Assurance; or a minimum of 2 years of relevant experience with an advanced degree (Master's or higher).
• Bachelor's degree in Microbiology, Biotechnology, Biomedical Engineering or related field.
• Strong communication and interpersonal skills with the ability to articulate technical concepts across all levels.
• Strong working knowledge of relevant standards and regulations (e.g., ISO 11135, ISO 13485, FDA, PMDA).
• Direct experience with EO sterilization processes, equipment, controls and change management, including parametric release processing.
• Demonstrable knowledge of microbiological testing, including bioburden, endotoxin and environmental monitoring.
• Proficiency in written and spoken English and Malay is required; ability to communicate technical concepts clearly and effectively.

·       Certifications in sterilization, microbiology, or quality systems (e.g., Certified Quality Engineer).

·       Experience with medical device sterilization processes, including EO sterilization and liquid sterilization methods (e.g., Glutaraldehyde).

Other Attributes:

• Demonstrates high ethical standards and integrity in all actions and decisions.
• Flexible and adaptable to changing priorities, challenges, and environments.
• Strong team player, including cross-functional teams, with a collaborative mindset.
• Meticulous attention to detail and commitment to quality.
• Provides technical guidance and mentorship to less experienced engineers.
• Excellent problem-solving skills.
• Proven project management and interpersonal skills.
• Excellent organizational and judgment skills.

What's in it for you:

This role offers innovative projects, strong culture and excellent opportunities for career progression. Additionally, it's an opportunity to be part of a transformative greenfield project that will contribute to our client's ongoing commitment to improving healthcare globally while supporting local communities in Malaysia.

We offer a competitive package including salary, incentives, medical coverage and paid leave. This role also includes international training, providing exposure to global best practices and end-to-end processes.