Change Management Specialist

2 weeks ago

Lansdale, United States Insight Global Full time

Must Haves:

  • Bachelor's degree in Engineering or Science
  • Experience in a Regulated Manufacturing Environment (Pharmaceutical, Oil, Food, Cosmetics)
  • MS Project Experience - Project Management or Project Tracking/Scheduling
  • 2+ years of change control management experience
  • Technical Writing experience

Pluses:

  • Pharmaceutical Manufacturing experience preferred
  • IPI, Trackwise or Veeva Vault experience
  • Experience working with Fermenters, Purification Equipment, Chromatography, or filling lines

Job Description

One of our large pharmaceutical clients located in West Point, PA is seeking a Change Management & Project Specialist to join the Bio Bacterial Manufacturing Team. This need is based upon the expansion of the recombinant vaccine supply chain. Increased manufacturing capacity requires implementation of process changes. Each change that occurs in the manufacturing process needs to be assessed and justified. This includes technical information on the process development studies performed to support the modifications, detailed implementation tasks with associated acceptance criteria, and confirmation from all affected stakeholder groups to ensure only positive impacts.

The specific projects that will be supported are related to: drug substance, re-dispense process, dual sourcing of filters, & environmental monitoring process updates. The overall project goals are to increase efficiency and production. The change management group handles all structure changes in IPI or Veeva vault.

Responsibilities:

  • Establish and manage project schedules and timelines
  • Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
  • Responsible for stakeholder engagement, communication, and risk escalation.
  • Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
  • Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
  • Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
  • Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
  • Provide technical support to manufacturing for problems and issues.
  • Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.

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