Laboratory Technician II

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 67,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. offers opportunities in a regulated analytical laboratory environment.

The role focuses on environmental control testing, endotoxin and bioburden analyses, and routine analytical testing to support quality systems. Qualified candidates bring 2–5 years of lab experience, GMP/GLP understanding, and hands-on skills with HPLC/GC, FTIR, and dissolution testing.

Qualifications

• Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines.
• 2-5 years of relevant laboratory experience in an analytical or quality control laboratory.
• Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing).
• Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable.
• Experience performing routine laboratory testing.

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 for accredited laboratory) and ensure all training is completed as per Laboratory Training Program.
• Delivery of key Quality and Performance Objectives.
• Conduct testing according to written procedures - Environmental Control testing of controlled areas within the plant, Endotoxin and Bioburden testing for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support.
• Collect, compile and analyse data and prepare laboratory reports.
• Ensure notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.
• Assist manufacturing/operations/quality in solving quality-related problems.
• Ensure NCE's, laboratory investigations and out of specification results are documented and reported to Laboratory Management.
• Ensure equipment standards and other materials are approved/released prior to use.
• Performs cleaning, preventative maintenance, verification of instruments and equipment where required.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Support Internal/External Audits.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• To build quality into all aspects of work by maintaining compliance to all quality requirements.
• Perform and assist with additional duties as may be directed by the Supervisor.

Skills

Attention to detail

Communication skills

Teamwork

Problem solving

GMP/GLP knowledge

Education

Bachelor’s or Diploma in Analytical Chemistry/ Chemistry/ Pharmaceutical Science/ Chemical Engineering/ Biotechnology/ Materials Science

Tools

HPLC/GC

FTIR

Dissolution Testing

pH Meter

Analytical/Micro Balance

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. 4.2 View all jobs

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accredited laboratory) and ensure all training is completed as per Laboratory Training Program.
• Delivery of key Quality and Performance Objectives.
• Conduct testing according to written procedures - Environmental Control testing (including water/air & surface microbial/air particulate) of controlled areas within the plant, Endotoxin and Bioburden testing (routine/ batch release/ validation) for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support.
• Collect, compile and analyse data and prepare laboratory reports.
• Ensures all notebooks/logbooks/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 in solving quality-related problems.
• Ensures NCE's, laboratory investigations and out of specification results are documented and reported to Laboratory Management.
• Ensure equipment standards and other materials are approved/released prior to use.
• Performs cleaning, preventative maintenance, verification of instruments and equipment where required.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Support Internal/External Audits.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• To build quality into all aspects of work by maintaining compliance to all quality requirements.
• Perform and assist with additional duties as may be directed by the Supervisor.

• Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines.
• 2-5 years of relevant laboratory experience in an analytical or quality control laboratory.
• Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing).
• Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable.
• Experience performing routine laboratory testing.

• Hands-on experience with analytical instrumentation such as HPLC/GC, FTIR, Dissolution Testing, pH Meter, and Analytical/Micro Balance.
• Sample preparation and handling techniques.
• Calibration, verification, and routine maintenance of laboratory equipment.
• Ability to troubleshoot minor instrument issues.
• Knowledge of method execution according to validated procedures.
• Understanding of GMP, GLP, Good Documentation Practices (GDP), and Data Integrity (ALCOA+ Principles).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 / Quality Management System requirements is preferred.
• Knowledge of laboratory safety and chemical handling.
• Strong attention to detail and adherence to quality requirements.
• Good communication and teamwork skills.

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.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.