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.