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Process Engineer

Process Engineer
Prince Edward Island
North America
Process engineer will focuses on the design, operation, control, and optimization of Engineering upstream & downstream processes for the manufacture of vaccines.

Functions, Duties, Task:

Provide stewardship for process and equipment including
  • Review the basis for the qualification of equipment and ensure that the equipment/system is appropriate for intended purpose
  • Ensure significant changes, maintenance and other interventions do not impact the qualified state of the equipment & provide maintenance oversight for process equipment.
  • Conduct or oversee periodic reviews of direct impact facilities, utilities equipment and systems to verify that they remain in state that is fit for their intended use
  • Create & revise qualification packages for direct impact systems & work with TSMS to ensure the accuracy of process flow documents
  • Provide oversight to less experienced engineers
Implementation and optimization of Process systems
  • Serve as local subject matter expert for process engineering systems
  • Ensure process operations comply with all Health, Safety, and Environmental policies and procedures.
  • Ensure process operations are in alignment with current site interpretations of GMPs & Elanco quality standards
  • Perform/ oversee Haz-ops and other process safety reviews.
  • Know and understand throughput and capacity, and implement improvements and problem solving to optimize the system performance.
  • Network with system users to ensure their needs are always met.
Execute local engineering projects
  • Provide Process Engineering support to project team
  • Participate as required in teams, committees or other groups to achieve goals
  • Work with project requester to determining the scope of the project.
  • Write user requirements document.
  • Complete Environmental Assessments
  • Write and execute commissioning documents to verify project success
  • Revise drawings and P&ID’s as needed and organize drafting updates
  • Confirm CADD revisions and sign drawings.
  • Assist in development of training plans & execute training as required
  • Review, revise & create Process Engineering documentation, validation requirements & user requirements as required

Write change management, incident reports, and complete corresponding action items
  • Act as investigation lead for Deviations related to Process systems and apply Root Cause Analysis to the investigation.
Other Duties
  • Complete documentation review for items generated or completed by the other process engineers and technicians. Provide technical assistance and backup support as necessary to these individuals.
  • Monitor all training requirements as defined in the ITP for this position, and ensure that training is completed by the required completion date.
  • Ensure that all necessary items are entered in the quality plan and that items are completed by the required date
  • BS Degree level in Chemical or Mechanical Engineering
  • 2-5 years experience with process engineering principles
  • Experience in a pharmaceutical, Biotech or related environment preferred
  • Proven analytical thinking and trouble-shooting skills
  • Strong oral, written, and interpersonal communication skills
  • Demonstrated ability to work independently and be a self-starter
  • Proven ability to multi-task
  • Strong attention to detail
  • Experience in validation activities associated with aseptic process, technology transfer and process validation
  • Experience in FMEA ,QRM, P&ID development, PFD development
  • Exposure to Lean-Six sigma principles
  • Experience in fermentation and cell technology
  • Flex hours possible