Specialist, Engineering

Applied Pharmaceutical Innovation (API) brings life‑saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

We are seeking a hands‑on Engineer to support the installation, commissioning, qualification, validation, improvement, and ongoing operation of GMP manufacturing equipment and facilities.

This role combines engineering, equipment reliability, and validation responsibilities, requiring a practical engineer who is comfortable working both on the production floor and in the office developing technical documentation.

The successful candidate will support equipment across pharmaceutical manufacturing operations including filling systems, inspection equipment, autoclaves, process tanks, CIP/SIP systems, packaging lines, utilities, clean rooms, HVAC systems, and supporting infrastructure. The individual will work closely with Operations, Maintenance, Quality, Automation, Validation, and external vendors to ensure equipment remains reliable, compliant, and validation‑ready throughout its lifecycle.

The ideal candidate will bring hands‑on GMP experience with strong involvement in equipment design review, facility and utility systems, troubleshooting, qualification activities, and operational support within a pharmaceutical manufacturing environment.

• Please note this position requires full‑time on‑site presence.

Engineering and Equipment Support

• Support installation, startup, commissioning, and operational readiness of new manufacturing equipment and facility systems.
• Serve as the engineering Subject Matter Expert (SME) for assigned equipment and manufacturing systems throughout the equipment lifecycle.
• Review equipment manuals, technical specifications, commissioning packages, engineering drawings, P&IDs, layouts, and vendor documentation.
• Support equipment design reviews to ensure systems meet GMP, operational, maintainability, and validation requirements.
• Coordinate with equipment suppliers, contractors, and project teams during equipment fabrication, installation, FAT, SAT, commissioning, and startup activities.
• Travel within Canada and internationally, as required, to participate in vendor FATs, training, and technical meetings.
• Support project teams in resolution of technical issues related to equipment installation, integration, qualification, and operation.
• Review construction QA/QC turnover documentation and commissioning records to ensure qualification readiness.
• Participate in root cause investigations and implementation of corrective and preventive actions (CAPA).
• Support continuous improvement initiatives focused on equipment reliability, maintainability, and operational efficiency.

• Assist with preparation, review, and execution of qualification protocols, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Develop and review:
  • User Requirement Specifications (URS)
  • Validation Plans
  • Risk Assessments (FMEA)
  • Traceability Matrices
  • Qualification Protocols and Reports
• Participate in FAT and SAT activities to verify equipment performance and compliance with user requirements.
• Support commissioning and qualification of GMP manufacturing equipment, clean rooms, process utilities, HVAC systems, and facility systems.
• Assist in qualification of clean rooms, including smoke studies and environmental classification activities.
• Support media fill activities, aseptic process validation, and qualification activities where applicable.
• Support Computer System Validation (CSV) activities for equipment, automation systems, and associated software platforms.
• Maintain equipment and systems in a validated…