Beschreibung

In this role, you will focus on device assembly and packaging, ensuring process validation and providing technical leadership. Your day-to-day responsibilities will include mentoring team members, managing risk, and driving improvements while collaborating with internal and external partners.

Anforderungen

• •Bachelor's degree or higher in engineering, packaging science, or related field
• •2+ years experience in a manufacturing organization
• •5+ years experience in a manufacturing organization
• •Pharmaceutical and/or medical device and packaging manufacturing experience
• •Root cause investigation experience
• •Proficiency with Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
• •Successful leadership of cross-functional teams
• •Strong interpersonal and teamwork skills
• •Strong self-management and organizational skills

Aufgaben

• •Own the technical agenda for device assembly and packaging processes
• •Mentor TSMS process team members and provide technical guidance
• •Support device assembly and packaging process teams as a TSMS representative
• •Serve as floor-level support and technical interface for device and packaging components
• •Represent the Alzey TSMS team in internal and external communications
• •Lead risk management activities related to product and process
• •Provide technical support for non-routine investigations, including quality and stability issues
• •Prepare and review relevant technical documents such as annual product reviews and change controls
• •Prepare and review PQ and PV protocols and reports
• •Develop and monitor statistically based metrics to assess process variability and capability
• •Identify opportunities and lead technical projects to enhance process control and productivity
• •Interface with upstream suppliers and global device/drug product networks
• •Drive stability strategy for Alzey products
• •Provide audit support as needed
• •Participate in projects to improve process control and productivity

Tools & Technologien