Validation & Quality Engineering SME
- Toronto, ON, Canada
Contract
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Job details
- Job type
- Contract
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- Posting language
- English
- Posted
Original job description
Role overview
Validation and quality engineering professional who rebuilds the cleaning validation program and supports facility, equipment and engineering remediation. Candidates must meet the minimum experience for both cleaning validation and validation / quality engineering.
Key responsibilities
- Run a gap assessment of the cleaning validation program; define cleanability, worst-case matrix, limits (e.g. HBEL/PDE-based) and swab locations
- Write cleaning validation protocols, support execution and write reports; set up periodic review
- Assess facility and equipment condition; prioritize maintenance work orders by quality risk
- Define clean-down and release evidence and room/equipment readiness criteria
- Integrate corporate engineering remediation actions; support process qualification and change management
- Review qualification protocols and reports for technical and GMP adequacy
Mandatory requirements
- 5+ years in cleaning validation strategy and execution in pharmaceutical manufacturing
- 5+ years in validation or quality engineering, including protocol and report review
- Knowledge of equipment qualification (IQ/OQ/PQ), change control and risk management (ICH Q9)
- Experience with cross-contamination control in multi-product facilities
Plus the common requirements listed on page 1.
Preferred qualifications
- Solid oral dosage multi-product facility experience
- Experience with HBEL/PDE toxicological limit setting
- Engineering degree (chemical, mechanical or similar)
Experience supporting facility remediation after quality events (e.g. foreign matter)
More about this job
Responsibilities
Assess and rebuild the cleaning validation program, including defining worst-case scenarios, limits, swab locations, protocols, execution support, reports, and periodic reviews. Evaluate facility and equipment condition, prioritize remediation by quality risk, establish readiness and release criteria, and support engineering remediation, process qualification, and change management.
Requirements
Candidates must have at least five years of cleaning validation strategy and execution experience in pharmaceutical manufacturing, plus at least five years in validation or quality engineering, including protocol and report review. They should know equipment qualification, change control, ICH Q9 risk management, and cross-contamination control; solid oral dosage experience, HBEL/PDE limit setting, an engineering degree, and facility remediation experience are preferred.
Skills
- Cleaning Validation
- Validation Strategy
- Quality Engineering
- GMP Compliance
- Equipment Qualification
- IQ/OQ/PQ
- Change Control
- Risk Management
- ICH Q9
- Cross-Contamination Control
- Protocol Development
- Report Review
- Facility Remediation
- Process Qualification
- HBEL/PDE Limit Setting
- Multi-Product Manufacturing
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Manufacturing
- Science & Research
- Healthcare
Keywords
- Cleaning Validation
- Pharmaceutical Manufacturing
- Validation Engineering
- Quality Engineering
- GMP
- Gap Assessment
- Cleanability
- Worst-Case Matrix
- HBEL
- PDE
- Swab Locations
- Cleaning Validation Protocols
- Periodic Review
- Equipment Qualification
- IQ/OQ/PQ
- Change Control
- ICH Q9
- Risk Management
- Cross-Contamination Control
- Multi-Product Facilities
- Facility Remediation
- Maintenance Work Orders
- Process Qualification
- Engineering Remediation
- Room Readiness
- Equipment Readiness
- Solid Oral Dosage
- Toxicological Limits
- Quality Events
- Foreign Matter