Validation Engineer - CQV

Job Title: Validation Engineer (CQV)

Company: Intellectt Inc.

Location: North York, Ontario, Canada

Employment Type: Contract - 12+ Months

Job Responsibilities

• Execute commissioning, qualification, and validation (CQV) activities for pharmaceutical, biotechnology, and other regulated manufacturing facilities.
• Develop, review, and execute validation documentation, including User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support equipment qualification, process validation, utility qualification, and facility commissioning activities in accordance with project requirements.
• Prepare and review validation protocols, test scripts, summary reports, deviations, and other quality documentation.
• Collaborate with engineering, quality assurance, manufacturing, and project teams to ensure equipment and systems meet design specifications and regulatory requirements.
• Support FAT/SAT, commissioning tests, protocol execution, discrepancy resolution, and corrective actions as required.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• Experience in Commissioning, Qualification, and Validation (CQV) within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Knowledge of equipment qualification, utility systems, process validation, and commissioning methodologies.
• Experience developing and executing IQ/OQ/PQ protocols and preparing validation reports.
• Familiarity with GMP requirements, quality systems, change control, deviation management, and risk-based validation approaches.

Pay Scale

• Anticipated hourly pay range: To be determined based on experience, qualifications, and applicable Canadian employment requirements.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: Retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable provincial and local laws.