Senior Specialist, Technical Operations

Job Description

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus areas of the role include (1) coordination and technical development of projects within the Packaging IPT, and (2) management of the Packaging Artwork program and portfolio.

Additional areas of responsibility may include Deviation Management, protocol development and execution, shop floor support of technical issues and management of the update of Packaging Master Batch Records.  Limited additional shift or weekend coverage may be required based on specific assignments.

Responsibilities of this role include:

Projects

• Providing leadership to the coordination and technical development of projects within the Packaging IPT.

• Managing Change Request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Summarizes project progress, delays, and improvement opportunities.

• Authors Change Requests and performs impact assessments and technical reviews of Change Requests within the Packaging IPT.

• Requesting master data changes in SAP in support of change control activities.

Artwork

• Managing all aspects of West Point Packaging Artwork, including site support as the QMS Topic 6.9 Sub-System Owner.

• Coordination and execution of Packaging Artwork workflow processes and projects in support of new and revised artwork.

• 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.

• The role will include support to the Packaging Component Artwork workflow approval process and associated requirements include ensuring appropriate specifications and details in the GLAMS system for printed components via workflows are complete.

• Collaboration with Planning, Quality, Data COE and the market to ensure On-Time delivery of printed components and final packaged material while maintaining compliance.

• Technical Operations lead for serialization.

General

• Collaborating effectively with the area Operators/Mechanics, support groups, Quality, and Planning.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations, as required.

• Supporting team and IPT safety, environmental, and compliance objectives.

• Actively using and championing the use of our Company Production System (MPS) tools, both in problem solving and day-to-day operational activities.

• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

• Provides technical support to manufacturing for complex problems and issues including process/equipment.

Required Education / Experience:

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging science or related discipline.

• Minimum 4-years experience in pharmaceutical manufacturing, packaging, or equivalent experience.

Strongly Preferred Experience:

• Minimum 2-years experience in the Change Control Process

• Minimum 1-year experience in the Artwork development/approval processes

• IPI, MEDS, MIDAS, GLAMS

• SAP Master Data submission experience

• Technical writing (e.g. change control, technical protocols/reports)

• Experience in Protocol Development

• Experience in applying our Company Production System (MPS) tools and mindset, both in problem solving and day-to-day operational activities

• Experience in application of serialization requirements

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posti