job description
Join West Pharmaceutical Services, a global leader in healthcare packaging and delivery systems, as we expand our Operational Excellence (OPEX) team in a cutting-edge cGMP manufacturing environment. This newly created role offers a unique opportunity to drive continuous improvement, optimize processes, and ensure compliance with the highest industry standards in our growing Bali operations.
As an OPEX Engineer, you will play a pivotal role in enhancing efficiency, reducing waste, and fostering a culture of excellence across our production facilities. Your expertise in Lean Six Sigma, process optimization, and regulatory compliance will directly impact our ability to deliver life-saving pharmaceutical solutions to patients worldwide.
Based in the vibrant Badung region, this position combines professional growth with the unparalleled lifestyle of Bali—where innovation meets inspiration.
Responsibility
- Lead and implement Lean Six Sigma methodologies (DMAIC, Kaizen) to drive process improvements and eliminate inefficiencies in cGMP manufacturing.
- Develop and monitor KPIs and performance metrics to track operational excellence, identifying areas for cost reduction and quality enhancement.
- Collaborate with cross-functional teams (Production, Quality, Maintenance) to standardize workflows and ensure adherence to FDA, EMA, and ISO 13485 regulations.
- Conduct root cause analysis (RCA) for deviations, non-conformances, and process failures, implementing corrective and preventive actions (CAPA).
- Design and deliver training programs on OPEX principles, fostering a culture of continuous improvement among staff.
- Optimize production layouts, material flow, and inventory management to minimize lead times and maximize throughput.
- Support new product introductions (NPI) by applying DFM (Design for Manufacturability) and DFSS (Design for Six Sigma) principles.
- Prepare and present executive reports on OPEX initiatives, ROI analysis, and long-term strategic recommendations.
Qualifications
- Bachelor’s degree in Mechanical, Industrial, Chemical Engineering, or related field. Master’s degree or Six Sigma Black Belt certification is a plus.
- Minimum 5 years of experience in OPEX, process engineering, or continuous improvement within pharmaceutical, medical device, or biotech industries.
- Proven expertise in Lean Manufacturing, TPM (Total Productive Maintenance), and Value Stream Mapping (VSM).
- Strong knowledge of cGMP, FDA 21 CFR Part 820, and ISO 13485 quality systems.
- Proficiency in statistical analysis tools (Minitab, JMP) and process simulation software (e.g., FlexSim, Arena).
- Excellent project management skills with experience leading cross-functional initiatives.
- Fluency in English (written and verbal); knowledge of Indonesian is advantageous.
- Strong problem-solving, communication, and stakeholder management abilities.