Position SummaryThe Packaging Engineer will join our Bedford, Ohio team and be responsible for the packaging processes, supporting continuous operations, and for the finishing of products according to compliance requirements, customer specifications and quality standards. Validate processes for the complete packaging area. Provide subject matter expertise regarding the existing and future equipment in the packaging department. Support development of employee skills and competencies by creating and performing training both technically and GMP. Provide subject matter expertise regarding the existing and future equipment in the packaging department. Support development of employee skills and competencies by creating and performing technical and GMP training.
- Lead and establish the packaging area with implementing procedures
- Create, review and own URS, protocols for the Packaging lines
- Make sure that daily production is running optimally in terms of output and quality
- Establish framework and support daily structure in which the packaging area can run Packaging according to defined KPIs
- Ensure that current requirements for environment, safety and health issues are met within production
- Solve problems on the shop-floor, informing and including relevant stakeholders
- Include team members and relevant stakeholders in decision-making in regards to planning production or deadlines impacting key Packaging milestones
- Gather and share knowledge with other Xellia sites to ensure Packaging process consistency, and share best practices
- Make certain that Packaging equipment is maintained and aligns with current pharmaceutical regulatory requirements, industry standards, government regulations, and budgetary agreements
- Be present on shop floor to gain process knowledge, be available for questions and input, and to coach the Packaging Team Leaders
- Train and support all Packaging personnel according to Xellia's standards
- Report Packaging KPI status to key stakeholders
- Provide comprehensible, simple Standard Operating Procedures and Work Instructions by means of illustrations and pictures
- Ensure that the economics of the Packaging unit are aligned with the overall budget
- Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations.
- Oversee that processes are in cGMP compliance, and establish systems that identify opportunities for improvement.
- Bachelor's Degree in Engineering
- Preferred pharmaceutical or production manufacturing experience
- Experience with high speed automated packaging equipment and systems
- Knowledge of GMP
- Demonstrates a strong bias for action while being able to prioritize and direct activities
- across a large operation.
- Manage Stakeholders ensure collaboration across functions
- Master’s Degree in Engineering or in Natural Sciences preferred
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