Principal II, Packaging and Labelling Engineering

Alcon Indonesia; Batam; On-site; IDR 999.333.000 - 1.332.446.000; Full time

Job summary

A leading global eye care company in Indonesia seeks a Principal II in Packaging and Labelling Engineering. This role involves designing and validating compliant packaging solutions and optimizing packaging processes. Ideal candidates will have expertise in packaging design, material selection, regulatory compliance, and validation protocols specifically in the medical device and pharmaceutical industries. This position offers an opportunity to make a significant impact in eye care while working collaboratively in a dynamic environment.

Qualifications

• Experience in packaging design and engineering with a focus on medical devices or pharmaceuticals.
• Knowledge of regulatory standards such as FDA, ISO, and cGMP.
• Strong leadership skills for managing cross-functional teams.

Responsibilities

• Design, develop, and test compliant packaging solutions.
• Lead validation of packaging machinery and troubleshooting.
• Ensure compliance with regulatory requirements for packaging.

Skills

Packaging design

Material selection

Regulatory compliance

Validation protocols

Process optimization

Tools

Packaging machinery

Sealing systems

Labeling equipment

Job description

Principal II, Packaging and Labelling Engineering

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Senior Packaging and Labeling Engineer to lead the development, validation, and execution of packaging and labeling solutions for our products. This role involves working with vendors to build and validating packaging machines, ensuring compliance with regulatory requirements, and optimizing packaging processes to improve efficiency and sustainability. The ideal candidate will bring expertise in packaging design, material selection, labeling systems, and packaging machinery validation, particularly in industries such as medical devices and pharmaceuticals.

Manage related equipment and process validations as required under the Quality system change control process. Coordinate the integration of new products and processes into the manufacturing systems and processes.

Job 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 cycled times, 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:

• Work 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.

Regulatory & Compliance:

• 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.