Merck & Co.-posted 9 months ago
Full-time
Onsite • West Point, PA
Chemical Manufacturing

West Point Technical Operations is seeking a highly motivated individual to provide engineering technical support for a vaccine formulation and filling facility. The focus of the role includes Deviation Management, including Process and Environmental Monitoring Deviation investigations, and one or more additional areas of processing support responsibility/development to include technical support to Product Quality Complaints investigations, Digital Innovation team support, Deviation Management Huddle or CAPA coordinator, or process support for one of the filling lines or the formulation area (process improvement, equipment support, floor support, validation, or support to the update of Formulation/Filling Electronic Batch Records). The deviation management role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). The other areas of responsibility offer opportunity for further development and rotation to gain experience in different potential functional roles within Technical Operations. Limited additional shift or weekend coverage may be required based on specific assignments.

  • Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
  • Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
  • Manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate discussions to align with technology and quality approvers/representatives on deviation classification and impact assessment.
  • Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
  • Collaboration across IPT functional areas to drive robust processing and continuous improvement.
  • Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
  • Supporting team and IPT safety, environmental, and compliance objectives.
  • Managing investigation, 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.
  • Actively using and championing the use of 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.
  • Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.
  • 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.
  • Collaborates effectively with the area Operators/Mechanics, support groups, Quality, and Planning.
  • Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, or related discipline.
  • Minimum 1-year experience in vaccine/pharmaceutical manufacturing in a direct or supporting function.
  • Two or more years of vaccine/pharmaceutical manufacturing experience (Operations, Technology, or Quality).
  • Experience in Deviation management and/or Complaints.
  • Experience in a Filling/Formulation manufacturing area.
  • Experience in Trackwise, MEDS, SAP, GLIMS, DeltaV use.
  • Electronic Batch Record revision/review experience.
  • Technical writing (e.g. investigations, technical protocols/reports).
  • Investigative tools (e.g. 5-whys, fishbone).
  • Experience in applying Production System (MPS) tools and mindset, both in problem solving and day-to-day operational activities.
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