Role: Cleaning Validation Engineer
Location: Toronto, Canada
Duration: 12-Month Contract
Our client is seeking an experienced Pharma Cleaning Validation Engineer to support validation activities within a regulated pharmaceutical manufacturing environment. The ideal candidate will be responsible for developing, executing, and maintaining cleaning validation protocols to ensure compliance with GMP and regulatory standards.
Responsibilities:
- Author and execute Cleaning Validation Lifecycle documents including Validation Master Plans (VMP), protocols (IQ/OQ/PQ), and summary reports
- Perform MACO (Maximum Allowable Carryover) calculations using toxicological and PDE-based approaches to establish scientifically justified limits
- Design and execute swab and rinse sampling studies, including recovery studies and worst-case product selection
- Develop cleaning validation strategies for manual, COP, and CIP/SIP systems across manufacturing equipment
- Ensure compliance with cGMP, FDA 21 CFR Part 211, Health Canada, and ICH Q7/Q9 guidelines
- Conduct risk assessments (FMEA) to identify worst-case scenarios for equipment, products, and cleaning processes
- Support equipment qualification (IQ/OQ/PQ) and integration with cleaning validation requirements
- Perform trend analysis on cleaning data and recommend revalidation or continuous improvement actions
- Lead investigations for deviations, OOS/OOT results, and implement CAPA aligned with quality systems
- Review and approve SOPs, batch records, and change controls impacting validated cleaning processes
- Collaborate with QC for analytical method validation (TOC, HPLC) related to residue detection
- Ensure data integrity (ALCOA+) and compliance throughout validation documentation and execution
Technical Skillset Required:
- Strong expertise in cleaning validation methodologies and regulatory expectations
- Hands-on experience with analytical techniques (TOC, HPLC, UV) for residue analysis
- Knowledge of toxicology-based limit setting (PDE/ADE)
- Familiarity with solid oral, sterile, or biologics manufacturing equipment
- Proficiency in validation documentation and quality systems (TrackWise, Veeva, etc. preferred)
If this role doesn’t align with your profile, or if you’re exploring new opportunities in the life sciences industry, feel free to share your resume at eswar@intellectt.com