Specialist, Engineering

Run my Accounts AG; Edmonton; On-site; CAD 90,000 - 120,000; Full time

Job summary

Applied Pharmaceutical Innovation (API) is seeking a hands-on Engineer to support GMP manufacturing equipment and facilities through installation, qualification, and ongoing operation. You will work with Operations, Quality, and Validation teams to ensure equipment reliability and inspection readiness.

The role requires on-site presence in Canada, with travel to vendor FAT/SAT activities and international meetings as needed.

Qualifications

• Experience supporting GMP equipment throughout commissioning, qualification, and validation.
• Ability to review P&IDs, layouts, and control system architecture drawings.
• Experience with cleanrooms, HVAC, and process utilities.
• Willingness to travel between Edmonton API sites and internationally as needed.

Responsibilities

• Provide day-to-day engineering support to manufacturing operations after project startup.
• Assist with IQ, OQ, and PQ activities and related documentation.
• Review equipment manuals and engineering drawings for GMP compliance.
• Coordinate with vendors, contractors, and project teams during installation and commissioning.
• Maintain equipment and validation documentation to remain inspection-ready.

Skills

Hands-on engineering

GMP experience

Equipment design review

Cross-functional collaboration

Documentation proficiency

Education

Bachelor's Degree in Mechanical Engineering

Engineer-in-Training (EIT) designation, preferred

CEAB-accredited program preferred

Tools

AutoCAD

Autodesk Inventor

BIM Collaborate

Job description

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, cleanrooms, 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.

Key Responsibilities, include but are not limited to:

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.

Qualification and Validation

• 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, cleanrooms, process utilities, HVAC systems, and facility systems.
• Assist in qualification of cleanrooms, 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 state through change control, periodic review, deviation assessments, and requalification activities.
• Ensure qualification and validation documentation remains inspection-ready and compliant with GMP requirements.

Mechanical and Process Systems

• Interpret and review:
  • P&IDs, Process Flow Diagrams, Mechanical Drawings
  • Equipment Layouts, Utility Drawings
  • Control System Architecture Drawings
• Support pharmaceutical systems including:
  • Process Tanks, CIP/SIP Systems
  • Clean Utilities, HVAC Systems
  • Building Management Systems (BMS)
  • Autoclaves, Filling Equipment, Inspection Equipment, Packaging Equipment
  • Material Handling Systems

• Assist with equipment modifications, optimization projects, and engineering improvements.

Design and Facility Support

• Create and maintain equipment and facility layouts using AutoCAD.
• Develop and review 3D equipment and facility models using Autodesk Inventor.
• Manage and coordinate engineering documentation using BIM Collaborate.
• Support plant expansion projects, facility modifications, and equipment relocations.
• Verify installed systems align with approved engineering drawings, layouts, and design intent.

Manufacturing Operations Support

• Provide day-to-day engineering support to manufacturing operations after project startup and commercial operation.
• Work directly with operators and maintenance personnel to troubleshoot equipment and process issues.
• Support equipment setup, product changeovers, campaign transitions, and operational readiness activities.
• Monitor equipment performance and identify opportunities for reliability, throughput, and efficiency improvements.
• Lead and support equipment-related investigations, deviations, and root cause analyses.
• Implement and support equipment changes through formal change control processes.
• Support preventive maintenance optimization and equipment lifecycle management activities.
• Maintain engineering documentation, equipment technical files, and validation documentation throughout the operational lifecycle.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure assigned systems remain compliant, validated, inspection-ready, and operationally reliable.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering, Automation Engineering, or a related discipline.
• Engineer-in-Training (EIT) designation, preferred.
• Degree from a Canadian Engineering Accreditation Board (CEAB) accredited institution or equivalent recognized engineering program, preferred.

Experience:

• 3-5 years of engineering experience within pharmaceutical, biotechnology, API, medical device, or other regulated manufacturing environments.
• Experience supporting GMP equipment throughout commissioning, qualification, validation, and operational phases.
• Hands-on experience with equipment startup, design review, FAT, SAT, and execution of IQ, OQ, and PQ activities.
• Experience working on GMP facility projects including cleanrooms, HVAC systems, utilities, and process equipment.
• Experience supporting equipment troubleshooting, manufacturing operations, and equipment changeovers.
• Experience working directly with vendors, contractors, and multidisciplinary project teams.
• Basic understanding of industrial networks and integration between Operational Technology (OT) and Information Technology (IT) systems.
• Ability to review and interpret engineering documentation including P&IDs, layouts, mechanical drawings, utility drawings, and control system architecture diagrams.
• Working knowledge of: AutoCAD, Autodesk Inventor, BIM Collaborate
• Familiarity with Data Integrity principles in regulated GMP environments is preferred.
• Proven work experience in process and/or mechanical and/or electrical and/or qualification engineering
• Prepared User Requirement Specifications (URS) and related documentation for process equipment and utilities
• Familiarity with Data Management - Integrity and Records
• Familiarity with GAMP 5 principles is considered an asset.
  

Personal Competencies

• Exceptional communication and interpersonal skills, with the ability to interact with stakeholders at all levels
• Hands on, practical engineering mindset
• Excellent organizational, planning, and prioritization skills
• Analytical problem-solving and clear communication skills
• Comfort with ambiguity and cultural differences
• Excellent written communication and interpersonal skills
• Exceptional attention to detail
• Effective in a fast-paced start-up environment
• Proactive, analytical, results-oriented, and creative
• Fosters transparent, honest, and positive team environment
• Results-driven and process-oriented
• Required travel between Edmonton API sites
• Maybe required to travel to several worldwide locations of vendors/suppliers especially Canada, USA and Europe.
• Exposure to chemicals,