Engineering Consultant




Prince Edward Island



Job Description:

  • Provide stewardship for process and equipment including:
    • Documents periodic reviews of direct impact facilities, utility equipment, and systems to verify that they remain in the state that is fit for their intended use.
    • Review the basis for the qualification of equipment and ensure that the equipment/system is appropriate for the intended purpose.
    • Ensure significant changes, maintenance, and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment.
    • Create and revise qualification packages for direct impact systems and work with the TS/MS to ensure the accuracy of process flow documents.
    • Provide coaching to process teams and wider engineering team on technical challenges.
  • Implementation and optimization of process systems:
    • Ensure process operations comply with all health, safety, and environmental policies and procedures.
    • Owns site engineering HSE processes for example control of pressure systems.
    • Perform/oversee Haz-ops and other process safety reviews.
    • Works with HSE manager on Process Safety Management Gap analysis and owns actions to implement an improvement plan.
    • Owns Engineering gap analysis versus GMP, quality and engineering standards.
  • Prioritizes and implements plan:
    • Drives standard in assigned engineering site processes - for example, HVAC, autoclaves, aseptic utilities.
    • Serve as local subject matter expert for process engineering systems.
    • Network with system users to ensure their needs are always met.
    • Builds network through the global engineering team
  • Execute local engineering projects:
    • Provide process engineering support to the project team, on assigned projects.
    • Participate as required in teams, committees, or other groups to achieve goals.
    • Work with project requester to determine 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&IDs as needed and organize drafting updates.
    • Confirm CADD revisions and sign drawings.
    • Assist in the development of training plans and execute training as required.
    • Review, revise, and create process engineering documentation
  • Engineering Consultant Confidential:
    • 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 all 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.
    • Other duties as required.

Job Requirements:

  • A minimum of a Bachelor's degree in Chemistry is required.
  • 8 - 10 years' experience with process engineering principles in Biotech or Pharamceutical industry.
  • Experience in qualification and validation activities associated with aseptic processes are essential.
  • Demonstrated ability to work independently and be a self-starter is essential.
  • Proven analytical thinking and trouble-shooting skills.
  • Must have strong oral, written, and interpersonal communication skills.
  • Proven ability to multi-task and must have strong high attention to detail.
  • Experience in FMEA, QRM, P&ID development, PFD development is preferred.
  • Exposure to Lean-Six-Sigma principles is an asset.
  • Experience in fermentation and cell technology is an asset.