Microbiology Engineer

OrbusNeich Medical Company Limited; Bekasi; On-site; IDR 400,000,000 - 560,000,000; Full time

Job summary

OrbusNeich Medical Company Limited in Bekasi, West Java, Indonesia, is seeking a Microbiology Engineer to ensure microbiological safety and quality of medical products. This full-time role involves developing and applying microbiological test methods, conducting sterility and endotoxin testing, and supporting regulatory submissions.

The candidate will join a cross-functional team, maintain documentation, and mentor junior staff while staying current with industry regulations and best practices.

Qualifications

• Bachelor's degree in Microbiology, Biomedical Sciences, Pharmaceutical Sciences or related discipline.
• 3–5 years in microbiological testing or QA in medical devices, pharma, or healthcare.
• Knowledge of sterility, endotoxin testing and microbial identification.

Responsibilities

• Perform microbiological testing and analysis of medical devices and raw materials.
• Develop, validate and implement microbiological test methods per ISO, FDA and regulatory requirements.
• Conduct sterility and endotoxin testing and conduct microbial identification.

Skills

Microbiology

Quality Assurance

Sterility Testing

Endotoxin Testing

Microbial Identification

LIMS

Data Analysis

English Communication

Education

Bachelor's degree in Microbiology or related field

Tools

LIMS

Job description

About the role

OrbusNeich Medical Company Limited is seeking a talented Microbiology Engineer to join our team in Bekasi, West Java, Indonesia. This is a full-time position that plays a crucial role in ensuring the microbiological safety, quality and efficacy of our medical products. As a Microbiology Engineer, you will be at the forefront of our quality assurance and product development efforts, contributing significantly to our commitment to delivering safe and effective medical solutions to our customers worldwide.

What you'll be doing

Conducting microbiological testing and analysis of medical devices and raw materials to ensure compliance with relevant standards and regulations

Developing, validating and implementing microbiological test methods and protocols aligned with ISO, FDA and other regulatory requirements

Performing sterility testing, endotoxin testing, and microbial identification to verify product safety and quality

Preparing and maintaining detailed technical documentation, test reports and microbiological specifications

Collaborating with product development, manufacturing and quality assurance teams to identify and resolve microbiological quality issues

Conducting environmental monitoring and contamination investigations within production facilities

Ensuring laboratory equipment calibration, maintenance and proper functioning of microbiological facilities

Supporting regulatory submissions by providing microbiological data and supporting documentation

Training and mentoring junior laboratory staff on microbiological techniques and best practices

Staying current with advances in microbiology and regulatory requirements relevant to the medical device industry

What we're looking for

Bachelor's degree in Microbiology, Biomedical Sciences, Pharmaceutical Sciences or a related discipline

Minimum 3-5 years of professional experience in microbiological testing or quality assurance within the medical device, pharmaceutical or healthcare industry

Strong technical knowledge of microbiological testing methods including sterility testing, endotoxin testing and microbial identification

Demonstrated experience with ISO 11135, ISO 11137, ISO 14937 or other relevant sterilisation and bioburden standards

Familiarity with FDA and international regulatory requirements for medical devices

Proficiency in laboratory information management systems (LIMS) and data analysis software

Excellent attention to detail and strong analytical and problem-solving skills

Ability to work independently whilst contributing effectively to cross-functional teams

Strong written and verbal communication skills in English; Indonesian language skills are advantageous

Commitment to maintaining laboratory safety protocols and regulatory compliance

What we offer

OrbusNeich Medical Company Limited is committed to supporting the professional growth and wellbeing of our employees. We offer competitive remuneration packages, opportunities for continuous learning and development, and a collaborative working environment that values innovation and excellence. Our commitment to work-life balance means you'll have the flexibility to manage your professional and personal responsibilities effectively. We provide comprehensive health and safety support and foster a culture of respect, diversity and inclusion where every team member can thrive and advance their career within the organisation.

About us

OrbusNeich Medical Company Limited is a leading global manufacturer of medical devices committed to advancing patient care through innovative, safe and high-quality products. With a strong presence in the international healthcare market, we combine scientific excellence with rigorous quality standards to deliver solutions that make a meaningful difference to patients and healthcare professionals worldwide. Our dedicated teams across multiple locations work collaboratively to uphold our mission of providing trusted medical solutions and maintaining the highest standards of safety, quality and regulatory compliance.