Validation & Quality Engineer

GENERAL DESCRIPTION:

The Validation and Quality Engineer plays a key role in ensuring compliance with regulatory requirements, internal quality standards, and industry best practices. This role oversees the Validation Program, including scheduling, protocol development, sample collection, and evaluation, as well as managing the Calibration Program, IQ/OQ/PQ processes, and Temperature Mapping activities. The engineer will also assist the Engineering Department in the development and maintenance of drug packaging procedures to ensure alignment with cGMP guidelines. Additional responsibilities include conducting internal audits, supporting the execution of corrective and preventive actions, and driving root cause analysis and continuous improvement initiatives. Through close collaboration with cross-functional teams, the position ensures the consistent delivery of high-quality, compliant products and operations.

DUTIES/RESPONSIBILITIES:

• Develop, implement, and oversee the site Validation Program, including drafting protocols, executing validation and qualification activities (IQ/OQ/PQ), conducting sample collection, analyzing data, and preparing comprehensive reports in compliance with FDA, EU GMP, and ISO standards.
• Prepare and maintain the Validation Master Plan (VMP), defining scope, timelines, resource allocation, and priorities for all validation activities.
• Execute and supervise equipment and system qualification, process validation, and cleaning validation, ensuring all activities meet regulatory and company requirements.
• Conduct Temperature Mapping studies for production areas, storage locations, and refrigeration units; maintain and calibrate monitoring devices to ensure accuracy and reliability.
• Manage the Calibration Program, ensuring all instruments and critical equipment are routinely calibrated, accurately documented, and compliant with specifications.
• Collaborate with Engineering and Maintenance teams on equipment installation, repair, upgrades, and revalidation efforts.
• Participate in the evaluation, purchase, and validation of new laboratory or production equipment and temperature monitoring systems.
• Write, review, and maintain Standard Operating Procedures (SOPs) related to validation, calibration, and equipment operation, and provide training to staff to promote compliance and enhance understanding.
• Perform internal GMP audits across departments, document findings, and verify implementation of corrective and preventive actions (CAPA).
• Conduct GMP inspections and ensure adherence to all plant procedures, quality standards, and safety requirements.
• Assist in the development and continuous improvement of cleaning and sanitation procedures, ensuring regulatory and quality compliance.
• Maintain all validation documentation, logbooks, and tracking systems, ensuring traceability and data integrity.
• Support cross-functional teams by providing technical guidance on validation and quality activities to ensure efficient and compliant operations.

QUALIFICATIONS / REQUIREMENTS:

• B.Sc. in Sciences, Engineering, Quality Assurance, or a related field. Computer competency required. SPC and Quality Principles an asset.
• 3 years+ experience in related field
• Strong knowledge of GMP, validation principles, and regulatory requirements (FDA, Health Canada, ICH, etc.).
• Hands-on experience with internal audits, equipment qualification, and validation protocol development.
• Excellent documentation, organizational, and problem-solving skills.
• Strong communication and training abilities, with experience engaging employees at all levels.

Job Types: Full-time, Permanent

Pay: From $24.00 per hour

Benefits:

• Dental care
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking

Work Location: In person