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Principal I, Packaging and Labelling Engineering
ID01 PT. CIBA Vision Batam CompanyBatam, Indonesia30+ hari yang lalu
Uraian TugasWork with vendors and validate packaging machinery, including automated packaging lines, sealing systems, and labeling equipment. Develop and execute validation protocols (IQ, OQ, PQ) for new and existing packaging equipment. Conduct root cause analysis and troubleshooting of packaging machine failures. Ensure packaging equipment meets efficiency, quality, and compliance standards. Collaborate with equipment vendors to implement custom packaging solutions. Initiate change controls, validation and risk documentation within the quality system as required for new printing and P&L equipment, materials, process improvements and new labelling / P&L implementation Responsible to lead development of URS and specification of packaging equipment to suppliers. Coordinate with production, facility and quality department to install and validate new packaging machines. Assigned work adheres to H&S and environmental requirements Ensure all packaging and labeling solutions comply with regulatory requirements (e.g., FDA, ISO, EU MDR, cGMP). Support audits and risk assessments related to packaging, labeling, and machine validation. Maintain documentation for regulatory submissions and quality assurance. Excellent knowledge of the regulatory and compliance standards for Packaging and Labelling Process Optimization & Cost Management : Optimize packaging and labeling processes for efficiency, cost-effectiveness, and sustainability. Lead troubleshooting efforts for packaging-related manufacturing issues. Conduct root cause analysis and implement corrective actions for defects or inefficiencies. Work with supply chain and production teams to streamline packaging operations. Be part of project team to lead packaging and labeling projects from concept to execution, ensuring timelines and budgets are met. Collaborate with R&D, Quality, Regulatory, Manufacturing, and Marketing teams to align packaging with product requirements. Train and mentor junior engineers and packaging technicians. Bachelor's degree in science or engineering (Diploma holder with strong experience may be considered) 7 years of relevant experience Good understanding of packaging and labelling technology used in manufacturing Hands-on working with packaging and labelling equipment Good knowledge of validation process Medical devices or pharmaceutical manufacturing related industries Opportunity to work with a leading global medical device company. Collaborate with a diverse and talented team in a supportive work environment. Competitive compensation package and comprehensive benefits. Continuous learning and development opportunities.
Description
Packaging & Labeling Development :
- Design, develop, and test innovative and compliant packaging solutions that ensure product integrity and user safety.
- Lead labeling development, ensuring accuracy, clarity, and compliance with industry regulations.
- Coordinate with global Alcon functions to generate, review and align on the content and design of primary and secondary labelling for product updates
- Drive improvements in the Global Labelling Process (e.g. reducing review and approval cycletimes, involving all relevant stakeholders in label / packaging design phase)
- Function as Labelling SME for Audit support of existing product offerings
- Responsible to lead team members on communications and planning with R&D and MTO functions related to all packaging and labelling development and implementation activities, including impact of the P&L design and content on the packaging processes, manual and automation
Packaging Machine Design & Validation :
Regulatory & Compliance :
Project Leadership & Cross-functional Collaboration :
WHAT YOU’LL BRING TO ALCON :
Why Join Us :
Buat peringatan pekerjaan untuk pencarian ini
Engineering • Batam, Indonesia