Senior Process Engineer

2 weeks ago

Oakville, Canada GMP Engineering Inc. Full time

We are a specialized engineering company with international exposure and subject mater expertise in the design, fabrication and qualification of sterile, high purity and potent containment process equipment and plants. We are growing our company size and capabilities through recruitment of talented professionals. We offer a true creative engineering design work environment with a wide range of interesting projects in the bio-pharmaceutical, personal care and food industry.


Position

You shall be a leader of a cross-functional engineering and support team in the role of senior process engineer. You shall develop and deliver conceptual, preliminary and detailed design packages for GMP-compliant integrated process equipment and unit operations used in the manufacturing of pharmaceutical drug substances and products. This position offers a unique opportunity to work with skilled professionals on high profile international projects for industry leaders.


Responsibilities

- Development of Conceptual and Preliminary Facility Design including:

  • Design Basis Development
  • Process Feasibility Studies
  • Process Alternatives Evaluations
  • Preliminary Process Design Packages
  • Front End Engineering Design (FEED) Packages
  • Technical and Economic Evaluations
  • Preliminary Capital Cost / Operating Cost Estimates


- Development of Detailed Process Design including:

  • Process Mass Balance
  • Production Schedules
  • Process Simulation
  • Utility Calculations and Sizing
  • User Requirement Specifications (URS)
  • Process Flow Diagrams (PFDs)
  • Process Level Piping and Instrumentation Diagrams (P&IDs)
  • Equipment Plot Plans and Layout Drawings
  • Relief Device Sizing
  • Equipment Sizing and Specification
  • Equipment, Line, and Instrument Lists
  • Process Control Diagrams (PCDs)
  • Functional Design Specifications (FDS)
  • Process Design Level Cost Estimates (capital and operating)
  • RFP / Bid Packages
  • Commissioning & Qualification Protocols
  • Process Operating Manuals & Operating Procedures


- Management of client relationship within project scope

- Management of internal/external resources to ensure successful project delivery

- Supervision and mentorship of junior engineers


- Collaboration with project coordinator for on-time and on-budget project delivery

  • Monthly reporting of project status, identifying potential technical, budget and schedule risks


- Development of new proposals in collaboration with business development group, including:

  • Identifying key deliverables
  • Identifying internal/external resource skill set and quantity requirements


Essential Skills and Attributes

  • Experience in GMP-compliant automated skidded equipment design such as process tanks, fermenters, tangential flow filtration equipment, CIP units, etc.
  • Experience in the design and construction/installation of piping, instrumentation, and control systems.
  • Experience in start-up, commissioning and qualification of automated process equipment.
  • Experience interfacing with other disciplines including process control, facility design, CAD design, validation, and quality.
  • Ability to manage and coordinate cross-functional project teams.
  • Ability to prioritize multiple tasks.
  • Self-directed, resourceful, and able to work independently with minimal oversight.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast-paced multi-tasking environment.

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