job description
Join Becton Dickinson, a global leader in medical technology, as a Senior Quality Engineer specializing in Microbiology and Sterilization in our Bali facility. This pivotal role ensures the highest standards of product quality, safety, and compliance in our state-of-the-art manufacturing processes.
As a key member of our Quality Assurance team, you will oversee laboratory management, drive sterilization validation, and lead quality engineering initiatives to support BDâs mission of advancing healthcare worldwide. Your expertise will directly impact the reliability and efficacy of life-saving medical devices and solutions.
Based in the vibrant and strategic location of Bali, this position offers a unique blend of professional growth and work-life balance in one of the worldâs most sought-after destinations.
Responsibility
- Lead and manage microbiology laboratory operations, including testing, documentation, and compliance with ISO, FDA, and GMP standards.
- Develop, validate, and optimize sterilization processes (e.g., ethylene oxide, gamma, steam) to ensure product safety and efficacy.
- Conduct risk assessments and implement corrective/preventive actions (CAPA) for quality deviations.
- Collaborate with cross-functional teams (R&D, Production, Regulatory) to integrate quality controls into product development and manufacturing.
- Oversee environmental monitoring and contamination control programs in cleanroom and production environments.
- Prepare and review technical reports, SOPs, and validation protocols for internal and regulatory audits.
- Train and mentor junior staff on quality systems, aseptic techniques, and sterilization best practices.
- Stay abreast of emerging industry trends and regulatory updates to ensure continuous improvement.
Qualifications
- Bachelorâs or Masterâs degree in Microbiology, Biotechnology, Chemical Engineering, or a related field.
- Minimum 5+ years of experience in quality engineering, with a focus on microbiology and sterilization in medical device/pharmaceutical manufacturing.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
- Hands-on experience with sterilization validation (ISO 11135, ISO 11737) and bioburden/endotoxin testing.
- Strong analytical skills and proficiency in statistical tools (e.g., Minitab, JMP) for data-driven decision-making.
- Excellent communication and leadership skills to manage teams and stakeholder relationships.
- Certification in Six Sigma, Lean Manufacturing, or ASQ CQE is a plus.
- Fluency in English; knowledge of Indonesian (Bahasa) is advantageous.