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.
