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 & provide maintenance oversight for process equipment.
Create & revise qualification packages for direct impact systems & work with TS/MS to ensure the accuracy of process flow documents.
Provide coaching to process teams and wider engineering teams 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 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 standards in assigned engineering site processes – for example, HVAC, autoclaves, and 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 a 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, and 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 & execute training as required.
Review, revise & create process engineering documentation
Write change management, and 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.
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.
Qualifications:
A minimum of a Bachelor’s degree in chemicals is required.
8 to 10+ years of experience with process engineering principles in the Biotech or Pharmaceutical industry.
Experience in qualification and validation activities associated with aseptic processes is 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, and PFD development is preferred.
Exposure to Lean-Six Sigma principles in an asset.
Experience in fermentation and cell technology is an asset.