Microbiologist I

Boston Scientific Gruppe; Penang; On-site; MYR 100,000 - 150,000; Full time

Job summary

A global medical technology leader is looking for a Microbiologist in Penang, Malaysia. The candidate will conduct testing on routine and non-routine samples, reviewing data to ensure compliance with quality and regulatory standards. Ideal for fresh graduates or those with 1–2 years' experience, this role requires microbiological laboratory skills and analytical expertise. The position promises a chance to contribute to advancements in medical technology. Join a dynamic team dedicated to improving patient health worldwide.

Qualifications

• Open to fresh graduates or candidates with 1-2 years of experience.

Responsibilities

• Conduct testing according to written procedures.
• Review all data and associated reports for conformance.
• Provide support and guidance in cGMP and regulatory matters.

Skills

Microbiological laboratory skills

Analytical skills

Knowledge in microbiology medical device testing

Education

Degree in science in microbiology, biotechnology, chemical/industrial science

Job description

Purpose Statement

The purpose of the Microbiologist role is to conduct testing on routine and non‑routine samples, data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to Technician levels. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Key Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025).
• Conduct testing according to written procedures.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Ensure all training is completed as per Laboratory Training Program 92048659.
• Ensures all notebooks, logbooks and datasheets are completed and reviewed in a timely manner.
• Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
• Assist manufacturing/operations/quality personnel in solving quality‑related problems.
• Ensures NCE’s, laboratory investigations and out‑of‑specification results are documented and reported to Laboratory Management.
• Support internal and external audits.
• Provide direction to Technician I, II & III roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross‑functional project teams as required.
• Act as designee for Senior Microbiologist/Microbiologist II as required, overseeing the day‑to‑day operation of the microbiology laboratory.
• Coordinate and/or perform method validations of new products.
• Assist in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Documentation control – coordinate and update documentation within the laboratory to ensure all documents are controlled in line with requirements.
• Coordinate and train to ensure compliance with mandatory training requirements.
• Communicate any concerns about work processes regarding environmental impact, health or safety issues to the Senior Microbiologist.
• Assist in writing and updating procedures and work instructions.
• Assist and perform audit preparation (internal and external).
• Support the analytical lab if required.
• Review all laboratory quality systems to ensure compliance with cGMP.
• Participate in regulatory, internal (auditor/auditee) and vendor audit programs as required.
• Perform and assist with additional duties as may be directed by the Senior Microbiologist/Microbiologist/Lab Manager.

Requirements

• Minimum degree in science in microbiology, biotechnology, chemical/industrial science, or an equivalent field.
• Open to fresh graduates or candidates with 1–2 years of experience.

Required skills

• Microbiological laboratory skills, analytical skills, knowledge in microbiology medical device testing.

About Us

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.