Spclst, Engineering

Job Description

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus of the role involves providing technical leadership in the areas of project execution-including Change Requests (CRs)-and Artwork management.

For project execution, tasks may include overseeing all the CRs within Packaging and leading project review meetings with CR owners, Quality approvers, and project stakeholders; owning and providing technical input to CRs; authoring, executing, and supporting technical protocols in support of projects. Limited additional shift or weekend coverage may be required based on specific assignments.

For Artwork, tasks may include execution and approval of Packaging Component Artwork workflows in GLAMS and oversight of all artwork workflows to ensure quality execution by the team. This requires collaboration with Planning, Quality, Data COE and the market to ensure On-Time delivery of printed components and final packaged material while maintaining compliance.

• Owning CRs and performing impact assessments for CRs within the Packaging IPT.
• Providing on-the-floor support of operational and technical issues related to projects and artwork.
• Providing project engineer support, developing plans, summarizing project progress, delays, and identifying improvement opportunities. Includes communicating with manager and stakeholders about status of projects and risks to meeting deliverables.
• Supporting team and IPT safety, environmental, and compliance objectives.
• Authoring and updating technical and manufacturing documents necessary for change control projects and artwork changes.
• Processing Artwork workflows on-time with consideration and management of meeting Pack by and Sell by dates and Regulatory Definitions.
  
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• Ensuring component artwork meets critical supply requirements/deadlines by understanding supply chain and material movement, supporting the use of SAP to update component
• Revision tables and submit/process required BOM updates for Artwork workflows to include processing master data changes in SAP.
• Supporting and executing continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies.
• Actively using and championing the use of our Company's Production System and Closed Loop System tools, both in problem solving and day-to-day operational activities.
• Collaborating effectively with the area Operators/Mechanics, Quality, Automation, EMU, and Planning.

• Bachelor's/Master's degree in chemical engineering, mechanical engineering, biological sciences, packaging science or related discipline, or equivalent work experience
• Minimum 2 years' experience executing problem solving or technical projects in a pharmaceutical manufacturing environment.

• Prior leadership experience (e.g. leading projects)
• Technical writing (e.g. qualifications, technical protocols/reports, investigations)
• Project management and/or artwork management
• Reviewing and approving technical documents (e.g. change controls, technical protocols/reports, qualifications)
• Utilizing our Company's Production System and Closed Loop System tools, such as 8-Step Problem Solving method for manufacturing issues
• Fluency with SAP, MEDS, Veeva, eVal
• Experience in application of serialization requirements

Adaptability, Adaptability, Analytical Instrumentation, Automation Systems, Biological Sciences, Biomedical Sciences, Bioprocessing, cGMP Compliance, Change Control Processes, Change Controls, Chemical Engineering, Continuous Improvement, Data Analysis, Detail-Oriented, Electrical Systems, Engineering Support, Manufacturing, Mechanical Engineering, Mechanical Systems, Mechatronics, On Time Deliveries, Pharmaceutical Manufacturing, Problem Solving, Process Control, Project Management {+ 4 more}

Packaging

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