McNeil Consumer Healthcare, Fort Washington, PA
Package Engineering Consultant (Integrated Project Services) March 2012 – November 2014
• Support the McNeil Consent Decree team in the identification and remediation of gaps related to the packaging and container closure development process.
• Review and revise package development procedures to comply with corporate standards addressing process, procedure, documentation, organization, roles, infrastructure, metrics, and training against remediated procedures.
o Standard Operating Procedures (SOPs) evaluated and updated include: package component development (governance and documentation requirements), development of component specifications, including drawings, package component supplemental specifications, and related test methods for incoming inspection, and packaging line trials.
• Create technical protocol for the assessment and remediation of all active primary, secondary, and tertiary package component specifications to meet new standards and procedures.
o Lead cross-functional teams to support remediation activities per protocol including change control management, development of remediation plans and risk assessments for package component specification updates, host stakeholder meetings to ensure alignment with component suppliers, packaging sites (internal and external), planning, procurement, logistics, R&D packaging lab, and applicable quality units (e.g., supplier quality management, product support QA, incoming inspection, etc.), create and approve remediation reports and related documentation required to support evidence binders for consent decree verification. Systems used include cMAT, SAP, EDM, CONNECT, and ComplianceWire.
Pfizer Consumer Healthcare, Madison, NJ
Senior Packaging Engineer November 2010 – March 2012
• Senior Packaging Engineer responsible for Pfizer Consumer Healthcare’s Pain Management therapeutic area including the Advil and ThermaCare/Robax product lines. Support product launches, line extensions and manufacturing site transfers for dosage forms including tablets, caplets, gel caplets, liquid-gels, chewable tablets, liquid suspensions and heatwraps.
• Support testing for primary, secondary and tertiary packaging components by designing and coordinating distribution, child resistant / senior friendly, component equivalency, dose accuracy, reformulation and extractable/leachable studies.
• Support system development as Subject Matter Expert (SME) for business processes to standardize, improve efficiency, reduce errors in electronic specification systems including SAP, ELIS, ePALMs, Novamanage, and GDMS.
• Provide training to new engineers for all electronic specification systems utilized for the creation and maintenance of technical drawings, artwork, specifications, and Bills of Materials.
• Host bi-weekly Engineering team project and process change meetings.
• Participate in M4 Lean projects evaluating current drawing and artwork processes to implement improvements.
• Conducted text assessments on all Advil extended content bottle labels and cartons utilizing piggyback labels. Implemented material reductions; conducted adhesive equivalency studies to add alternate adhesives to all Advil label specifications with projected FY 2012 savings of $70,000.
• Maximized Advil and ThermaCare pallet pattern configurations increasing efficiency by coordinating with global external manufacturing, domestic manufacturing sites, and distribution centers.
• Coordinated ThermaCare site equipment refit and scale up by coordinating and designing line trials and distribution studies culminating in the design, and generation of greater than five hundred artwork and specifications for the improved equipment and processes.
Pfizer Pharmaceuticals (formerly Wyeth Pharmaceuticals), Collegeville, PA
Packaging Engineer III May 2007 – November 2010
Contract Packaging Engineer (Equity Packaging Inc.) August 2006 – May 2007
• Primary Package Engineer responsible for Tygacil IV, Protonix, Pristiq, Premarin and Prempro. Supported product launches, extensions and line transfers.
• Recommended solutions to packaging problems through interactions with Marketing, Regulatory Affairs, Operations, Quality Assurance, Procurement, Engineering, Technical Services, R&D, and Material vendors.
• Developed, improved, and co-approved specifications, Bills of Material, drawings, and other supporting documentation within Pfizer’s Technical Specification Systems.
• Coordinated package trials and component testing for the qualification and/or validation of new or revised package components and the installation of new production equipment.
• Worked with manufacturing sites and vendors to standardize specifications across all sites to impro...
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