job description
Join Novexx Pte Ltd, a leading European Multinational Corporation, as a Manufacturing Engineer in the Pharmaceutical sector. This is a unique opportunity to contribute to cutting-edge manufacturing processes in a dynamic, global environment. Based in the vibrant and culturally rich location of Bali, Indonesia, you will play a pivotal role in optimizing production efficiency, ensuring compliance with international pharmaceutical standards, and driving innovation in manufacturing technologies.
As part of our team, you will collaborate with cross-functional departments to enhance operational excellence, implement best practices, and maintain the highest quality standards in pharmaceutical manufacturing. This contract role offers a competitive salary, professional growth, and the chance to work in a diverse, international setting.
Responsibility
- Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness in pharmaceutical production.
- Ensure compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other international regulatory standards.
- Collaborate with R&D, Quality Assurance, and Production teams to scale up new products and processes from pilot to full-scale manufacturing.
- Design and execute process validation protocols, including IQ, OQ, and PQ, to ensure consistent product quality.
- Troubleshoot and resolve manufacturing issues, conducting root cause analysis (RCA) and implementing corrective and preventive actions (CAPA).
- Lead continuous improvement initiatives using Lean, Six Sigma, or other methodologies to enhance operational performance.
- Prepare and maintain technical documentation, including SOPs, batch records, and engineering change controls.
- Support the introduction of new manufacturing technologies, automation, and digitalization to drive innovation.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or a related field. Advanced degrees are a plus.
- Minimum 3-5 years of experience in pharmaceutical manufacturing, biotech, or medical device industries.
- Strong knowledge of GMP, FDA 21 CFR, ICH guidelines, and ISO standards.
- Proven experience in process development, validation, and scale-up within a regulated environment.
- Proficiency in Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
- Excellent problem-solving skills with the ability to conduct root cause analysis (RCA) and CAPA implementation.
- Strong communication and project management skills to collaborate effectively with cross-functional teams.
- Familiarity with automation, digitalization, or Industry 4.0 technologies in manufacturing is a plus.