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Plant Engineer

Burnaby, BC
Full Time
4 days ago
Job Summary

This position is responsible for providing engineering support for the manufacturing of drug products. The employee authors engineering documentation (SOPs, SOWs, Change Control, ETOP, Technical Manuals, Validation Protocols etc.); supporting pharmaceutical development and design; and/or participation in and supporting cGMP manufacturing activities.

This role will be part of implementing a centralized Site Engineering department at Vancouver whose responsibilities will include improving plant/asset reliability, executing CAPEX projects, and executing GMP compliant commissioning and qualification. This role supports mRNA-based projects by specifying and onboarding new assets for both the Production and Formulation departments.

  • Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies
  • Execute assigned projects from Conceptual design to Financial close.
  • Execute project activities in alignment with Good Engineering Practices (GEP) including but not limited to SOW development, vendors/contractor identification, change control management, author / execute / summarize ETOPs and validation protocols, and author SOPs or provide technical review.
  •  Read and review engineering drawings and update as required.
  •  Follow SOP’s, cGMP, and GLP regulations and procedures; generate and maintain thorough and accurate documentation by using Good Documentation Practices (GDP) in support of SOP, cGMP, and GLP regulated activities.
  • Develop and execute Commissioning & Qualification protocols.
  • Identify Continuous Improvement (CI) opportunities related to Facility maintenance, calibration, and facilities equipment, and procedures. Take corrective action independently and/or as directed by management.
  •  Assist in development and review of Technical manuals as required.
  •  Assist in development and review of Preventive Maintenance checklist and/or Guidelines and Calibration specifications as appropriate.
  • Prepare supporting documentation for projects of diverse scope and complexity. 
  •  Equipment design and selection; line design and installation
  • Incorporate Pharmaceutical Standards and cGMP’s into assigned projects as appropriate, i.e. USP and/or EU Standards.
  •  Provide training and/or technical support as needed.
  •  Serve as primary author for technical reports and summaries for small projects of varying scope and complexity


  • BS in a relevant engineering field (preferably in Chemical or Mechanical Engineering).
  • Three to Five (3-5) years commissioning and qualification experience in a highly regulated industry, preferably the pharmaceutical or medical device industry.
  • Knowledge of FDA, ISO, EU and Health Canada regulatory requirements and cGMP.
  • Knowledge and experience in the interpretation of GAMP, GEP, and ISPE guidances.
  • Experience with risk assessments and mitigations, root cause analysis and risk/hazard/failure analysis.
  • Able to apply principles of Quality by Design, Design for Six Sigma, Lean Six Sigma, etc.