First Officer operating Lear 75 private and charter passenger flights for an aircraft management company. Ensuring flight safety, regulatory compliance, and coordination with crew and operations teams.
About the role
- Validation Specialist managing high-risk validation projects for PCI Pharma Services, a biopharma services company. Preparing protocols, audit documentation, and compliance reports across specialized validation areas.
Responsibilities
- Own overall validation projects for high-risk projects under limited to no supervision
- Generate and execute validation protocols
- Assist with audits and determine validation needs
- Train Analysts
- Perform validation activities to ensure compliance with government and customer requirements
- Prepare validation protocols, statements, reports, summaries, and master validation plans for new customer, product, and system launches
- Maintain validated processes and programs at multiple sites
- Organize and coordinate internal and customer approvals
- Ensure validation documentation completion, accuracy, and closure
- Prepare change controls and validation history reports for audits
- Attend conference calls and meetings
- Communicate project goals and progress to the Validation Supervisor/Manager
- Investigate validation deviations, document formal reports, and ensure corrective-action resolution
- Serve as primary contact for quality validation activities and manage expectations
- Review and interpret standards, procedures, and specifications for validation protocols
- Specialize in one or more validation areas: Process/Cleaning, HVAC/Utility, or Computer Validation
Requirements
- Associate's Degree in a related field and/or 1-3 years related experience and/or training
- College-level mathematical skills
- Advanced computer skills and knowledge of most computer programs
- Full professional proficiency in speaking, reading, and writing
- Ability to solve practical problems and interpret varied instructions
- Knowledge of and adherence to PCI, cGMP, GCP, GAMP, 21 CFR, 21 CFR Part 11, and Annex 11 requirements
- Required to complete and pass Documentation Boot Camp and Train the Trainer courses
- Ability to work overtime and/or weekends as required
- Attendance at work is essential
- Process/Cleaning Validation Focus: background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices; ability to gown and work in an active packaging operation
- HVAC/Utility Validation Focus: familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and heating, air conditioning, and refrigeration systems
- Computer Validation Focus: ability to perform highly complex computer tasks and experience with computer systems impacting cGMP, cGXP, Annex 11, and PCI guidelines
Benefits
- Annual performance bonus eligibility
- Paid time off
- Extended health benefits, including dental and vision
- Life and disability insurance
- Retirement savings options such as an RRSP with employer contributions
- Wellness and employee-support programs may also be available
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