Validation Engineer

Job Summary

We are seeking a motivated and detail-oriented Validation Engineer to join our engineering team. This entry-level position is ideal for recent graduates or professionals with up to two years of experience who are interested in equipment, process, software, or system validation. The successful candidate will assist in planning, executing, and documenting validation activities to ensure compliance with quality standards, regulatory requirements, and company procedures.

Key Responsibilities

• Assist in developing and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support equipment, process, utility, and computerized system validation activities.
• Prepare and maintain validation documentation, including protocols, reports, SOPs, and test records.
• Execute validation tests and accurately document results.
• Review engineering drawings, specifications, and technical documentation to support validation activities.
• Assist in troubleshooting validation issues and participate in root cause investigations.
• Support change control, deviation investigations, and Corrective and Preventive Action (CAPA) activities.
• Ensure compliance with company quality standards, GMP, ISO, and applicable regulatory requirements.
• Collaborate with Quality Assurance, Manufacturing, Engineering, Maintenance, and Production teams.
• Participate in risk assessments using methodologies such as FMEA.
• Support equipment commissioning and qualification projects.
• Maintain validation schedules and ensure documentation is completed in a timely manner.
• Participate in internal and external quality audits as required.
• Assist in continuous improvement initiatives to enhance validation processes and operational efficiency.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, Mechatronics, or a related engineering discipline.
• 0–2 years of experience in validation, quality, manufacturing, or engineering (internship or co-op experience is an asset).
• Basic understanding of validation principles and engineering documentation.
• Familiarity with Good Manufacturing Practices (GMP), ISO standards, or quality systems is considered an asset.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Preferred Qualifications

• Internship or co-op experience in manufacturing, pharmaceuticals, medical devices, automation, or semiconductor industries.
• Knowledge of validation lifecycle concepts and documentation.
• Familiarity with FDA, Health Canada, ISO 9001, ISO 13485, or GAMP 5 guidelines.
• Experience with engineering documentation or quality management systems.
• Exposure to statistical analysis tools such as Minitab is an advantage.

Technical Skills

• Equipment Qualification (IQ/OQ/PQ)
• Process Validation
• Validation Documentation
• Risk Assessment (FMEA)
• Root Cause Analysis
• CAPA
• SOP Development
• GMP and GDP Documentation
• Microsoft Excel, Word, and PowerPoint
• Basic understanding of quality management systems
• Engineering drawings and technical documentation

What We Offer

• Competitive salary and benefits package
• Comprehensive training and mentorship
• Career growth and professional development opportunities
• Collaborative and inclusive work environment
• Exposure to advanced manufacturing and validation technologies
• Paid vacation and statutory holidays
• Health, dental, and vision benefits
• Retirement savings program (where applicable)

Keywords: Validation Engineer, Entry-Level Engineer, IQ, OQ, PQ, Process Validation, Equipment Validation, Quality Assurance, GMP, ISO 9001, ISO 13485, CAPA, FMEA, Engineering, Manufacturing, Medical Devices, Pharmaceuticals, Semiconductor, Canada.

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