Staff Microbiologist

Dexcom; Seberang Perai; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading global medical technology company in Penang is seeking an experienced Staff Microbiologist to oversee and enhance sterilization processes for implantable devices. The ideal candidate will ensure compliance with ISO standards, perform detailed microbiological testing, and manage risk assessments while collaborating with global teams. Candidates should have significant experience in the sterilization field and be familiar with relevant regulatory standards. Attractive growth opportunities and a comprehensive benefits program await the right candidate.

Benefits

Comprehensive benefits program

Growth opportunities

Access to career development programs

Qualifications

• 8-12 years of related experience in the sterilization field.
• Knowledge of relevant standards and regulations such as ISO 13485 and 21 CFR 820.
• Experience with permanent implantable devices.

Responsibilities

• Maintain regulatory compliance for sterilization of devices.
• Collaborate with global teams for innovation in sterilization methods.
• Perform microbiological tests and risk assessments.
• Conduct investigations and manage testing with contract labs.
• Prepare documentation and ensure audit readiness.

Skills

Sterilization

Risk assessment

Microbiology testing

Regulatory compliance

Environmental monitoring

Lab testing

Communication

Education

Bachelor’s degree in Microbiology, Biology or related field

Job description

The Staff Microbiologist will mainly in charge on strategically and collaborate across teams to innovate and implement gentler sterilization methods. Ensuring all cycle changes were validated and documented per ISO 11135 and internal quality systems, maintaining audit readiness and compliance. Maintain environmental monitoring program, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance with sterilization and microbiology testing standard.

Where you come in

You maintain regulatory compliance for the sterilization program of sterile implantable devices through process re-qualifications, new product qualifications, and comprehensive risk assessments.

You lead and ensure validation and documentation of all cycle changes in accordance with ISO 11135 and internal quality systems, sustaining audit readiness and compliance.

You collaborate strategically with global teams to innovate and implement gentler sterilization methods.

You drive product adoption and equivalence assessments for new SKUs within existing validated families; author and/or approve validation protocols, reports, and change controls.

You review cycle data (e.g., EO dwell time, humidity/temperature, EO concentration) and provide timely release recommendations; monitor trends and continuously improve cycle robustness.

You perform EO residual calculations and verification per ISO 10993-7 and internal specifications, coordinate aeration effectiveness evaluations and lot disposition assessments.

You prepare storyboards and evidence packages; serve as Subject Matter Expert (SME) during internal and external audits (e.g., BSI, FDA), ensuring continuous audit readiness for Microbiology & Sterilization.

You coordinate microbiological testing, product release, and validation protocol testing.

You interpret microbiological cultures and related tests, including environmental monitoring, sterility tests, growth promotion, microbial limits, and antimicrobial effectiveness testing.

You support environmental particulate and microbial testing for ISO-certified cleanrooms, HVAC systems, compressed air systems, and water systems.

You conduct laboratory testing such as bacterial gram staining, growth promotion, microbial identification, endotoxin testing, bioburden recovery, and sterility testing.

You manage testing with contract laboratories, including scheduling, sample submission, result review, investigations, and purchase order maintenance.

You perform risk assessments for deviations, out-of-specification (OOS) events, CAPAs, NCMRs, and COPs.

You develop and execute Performance Qualification and Validation protocols and reports.

You design and validate test methods to support microbiology operations.

You conduct risk assessments for manufacturing process changes, product development, material biocompatibility, and product modifications.

You ensure regulatory compliance for product and material biocompatibility through safety assessments and testing of sterile implantable medical devices for existing and new products.

You prepare process and status reports; assign and monitor document numbers; review documents for accuracy and completeness.

You perform supplier audits to assess changes impacting sterilization and biocompatibility.

You communicate effectively and professionally with internal and external stakeholders.

What makes you successful

You have experience in sterilization field (i.e. validation, risk assessment, new product adoption)

You have experience in monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water).

You able to communicate effectively and computer literate.

You have industry experience in medical, biopharmaceutical or pharmaceutical or similar environment.

You have knowledge of the following standards and regulations: 21 CFR 820, ISO 13485, CMDR, and EEC93/42, US and EU Pharmacopeia <85>, <161>, AAMI/TIR 30, AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11137, 11737, 14971, and other risk guidance standards.

You have experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing.

You have experience with pro-longed contact and permanent implantable devices

What you’ll get

A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

A full and comprehensive benefits program.

Growth opportunities on a global scale.

Access to career development through in-house learning programs and/or qualified tuition reimbursement.

An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required

0-25%

Experience and Education Requirements

Typically requires a Bachelor’s degree in Microbiology, Biology or related field, and a minimum of 8-12 years of related experience