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 Canadas 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

• Bachelors 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 machinery and equipment.
• Ability to safely preform site visits and inspections including walking on uneven terrain climbing stairs/ladders stranding/walking for extended periods and occasional lifting.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate with API matching of contributions up to 13% of base salary in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a pre-employment screening which includes background reference checks educational credential verification and criminal reference checks.

This position will remain open until filled.

Required Experience:

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