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Packaging Engineer

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The Package Engineer is responsible for design, development and support of package systems and processes for primary, secondary and tertiary packaging of onsite and external parenteral, solid oral dose and liquid pharmaceutical products. These activities support new and existing commercial products, Marketing initiatives, new market launches, and cost savings or to identify problems and improvements. This position will collaborate on product commercialization cross-functional project teams and continuous process improvement teams.

This position demonstrates high-level performance and delivers high-quality packaging on schedule to meet patient, company and regulatory needs. The Package Engineer will maintain and develop relationships with key suppliers and assist in packaging component related problem-solving activities with these suppliers.

Evaluate and write component specifications, Packaging Instructions, Lot Packaging Records, packaging related SOPs and Work Instruction Documents. 15%
Write packaging component/equipment Test Protocols. Develop action plans to ensure that protocol tests and evaluations are completed within established timeframes. 10%
Provide full support of packaging validation, equipment, processes and materials; subject matter expert (SME) review of validation protocols 5%
Plans and executes new component introductions to ensure on time delivery of commercial product and launch supply. 10%
Troubleshoot problems with existing packaging components and coordinate component modifications with suppliers. 10%
SME representation on new product initiatives, new market launch teams and process improvement teams. 15%
Accountable for Incoming Inspections and technical review of packaging component Incoming Inspection reports and of new and modified packaging component artwork. 15%
Initiation and ownership of Change Controls for packaging component changes. Coordination of new artwork requests; technical review of new and modified component artwork. Technical review of packaging component incoming inspection. 20%

The Package Engineer is an individual contributor with no direct reports. This position provides support for currently marketed pharmaceutical products packaged at external sites as well as New Product Initiatives and New Markets launches. Provides Subject Matter Expert (SME) representation on cross-functional/cross-site project teams, regulatory audits and process improvement initiatives.

The Package Engineer receives no instruction on routine work following initial task description determined by the Sr. Manager of Package Engineering. Provides independent technical and compliance review of peer’s work prior to final management approval. Ensures personal understanding of all quality policy/systems per assigned training curriculum. Follows all work/quality procedures to ensure quality and regulatory compliance. Leads improvement and standardization of packaging on existing products with focus on quality, performance and cost effectiveness.

Self-directed and with minimal supervision, the Package Engineer determines how best to manage multiple projects and tasks in order to meet challenging, shifting timelines. Develops action plans independently for new assignments or requests outside of the department. The Package Engineer receives limited review of work and mentoring and is expected to work independently to meet stated and required goals/target dates.

Collaborates with other functional groups within the company. Provides technical recommendations and implements changes for packaging processes and materials. Identifies and implements best practices, packages and processes. Actively engaged with suppliers for the testing and approval of materials and components.

Essential Requirements:
• Requires a BS degree in Package Engineering plus minimum 5 years related work experience, preferably in a pharmaceutical environment.
• Excellent oral and written communication skills; ability to communicate effectively with all levels of management
• Attention to detail and time management skills
• Ability to work on cross functional teams
• Knowledge of GMP, GLP, CFR, USP/EP/JP requirements
• Knowledge of ISO/ASTM/ISTA standards related to packaging
• Demonstrated initiative, results oriented, willingness and ability to institute change
• Process oriented with a strong interest in continuous improvement
• Demonstrated strong analytical skills and judgment
• Experience with packaging materials such as paperboard, adhesives, inks, glass, plastics, metals, films and labels
• Experience with automated and/or semi-automated pharmaceutical filling and packaging equipment and processes
• Knowledge of packaging and labeling design/test methods, verification/validation, various statistical tools, vendor and internal auditing, and protocol/report preparation
• Proficiency with MS Word and Excel

Additional Desirable Skills:
• Knowledge of MS Project, MS Access and SAP
• Knowledge of ROW regulations
• Knowledge of Serialization requirements for the pharmaceutical industry

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