Biotech Engineering Jobs in Saskatchewan (NOW HIRING)

Role: Validation Engineer (Pharma/Biotech)

Location: Ontario, Canada

Duration: 12 Months Contract

Summary: We are seeking an experienced Validation Engineer to support commissioning, qualification, and validation (CQV) activities within a regulated pharmaceutical/biotechnology manufacturing environment. The ideal candidate will be responsible for executing validation protocols, qualifying equipment and utilities, supporting process validation activities, and ensuring compliance with cGMP, Health Canada, FDA, and industry standards. This role requires strong technical expertise in validation lifecycle management, documentation, and cross-functional collaboration.

Responsibilities:

• Develop, review, and execute IQ, OQ, PQ protocols and validation reports for manufacturing equipment, utilities, facilities, and process systems.
• Support commissioning and qualification activities for new equipment installations and facility expansion projects.
• Perform equipment qualification, utility validation, and process validation activities in compliance with regulatory requirements.
• Author and maintain validation documentation including protocols, reports, risk assessments, and validation plans.
• Support cleaning validation and process performance qualification (PPQ) studies.
• Participate in FAT/SAT activities and assess qualification impacts for equipment modifications and changes.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Project teams to ensure timely project execution.
• Investigate deviations, implement CAPAs, and support change control activities related to validation programs.
• Review engineering and technical documents including URS, FRS, P&IDs, and design specifications.
• Ensure compliance with cGMP, Health Canada, FDA, ISPE, and GAMP 5 guidelines.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.

Required Skills:

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.
• 3+ years of validation experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Hands-on experience with IQ/OQ/PQ execution, equipment qualification, utility qualification, and process validation.
• Strong understanding of cGMP, FDA regulations, Health Canada requirements, GAMP 5, and validation lifecycle principles.
• Experience with change control, deviation investigations, CAPA management, and risk assessments.
• Knowledge of manufacturing equipment, clean utilities, HVAC systems, and facility qualification processes.
• Ability to author and review validation protocols, reports, and technical documentation.
• Excellent troubleshooting, analytical, and technical writing skills.
• Strong communication and collaboration skills in cross-functional project environments.
• Experience with validation management tools such as Kneat, TrackWise, MasterControl, Veeva, or similar systems is preferred.