Senior Process Engineer
Title: Senior Process Engineer – Pharmaceutical/Biotech Sector
Location: Toronto, Ontario
Must be flexible with Hybrid/Onsite work.
Experience: Minimum 5 years experience
Duration: 2+ years
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
Execute process engineering activities for strategic capital projects within the Toronto Engineering & Technical Services Organization. Required to ensure successful commissioning and qualification of GMP process equipment (fermentors, super skids, UF's, MF's, chromatography skids, centrifuges, lab equipment) by supporting startup and shakedown, and handover to end users. Responsible for interfacing with different trades (architecture/building, mechanical, electrical, automation) to ensure the correct installation of process equipment, utilities equipment and field piping while adhering to established regulatory compliance requirements. Responsible for developing appropriate solutions to ensure design intent is met and satisfies process, quality, and safety requirements in accordance with company guidelines and procedures, and within budget and schedule commitments.
• Act as system owner for process equipment and working with CQ execution team to support commissioning, as-building, and handover.
• Interpret process and manufacturing requirements developed during design phase
• Interpret process flow diagrams, piping and instrumentation diagrams, mass balances, process descriptions, and functional specifications to ensure proper installation of systems and piping in the field.
• Determine if there are gaps in the design and troubleshoot equipment and piping in the field. Responsible for understanding the process and utility requirements to ensure proper installation, commissioning and qualification.
• Perform appropriate reviews with stakeholders. Must ensure engineering contractor calculations are correct and review vendor designs for adherence to specification and best practice guidelines. Participate in peer reviews. Responsible for design that meets project budget and schedule.
Equipment and/or process design experience would be an asset
MUST HAVE GMP DESIGN EXPERIENCE IN BIOTECH/PHARMA