- Alliston, Ontario, Canada
- Entry
- CA$72K–CA$108K per year
- 5+ years
Lead validation initiatives for manufacturing equipment, processes, cleaning and computerized systems to ensure compliance with regulatory and quality standards.
Compensation
The estimated salary range for this position is $72,080.00 - $108,120.00 CAD annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan.
Responsibilities
- Lead the development, execution, and completion of validation programs for manufacturing equipment, processes, cleaning and computerized systems to ensure a validated state of control.
- Author validation protocols and reports, analyze validation data, and apply statistical techniques to demonstrate compliance with regulatory and quality requirements.
- Partner with Engineering, Production, Quality Control, and external vendors to plan, coordinate, and execute qualification activities including IQ, OQ, and PQ protocols.
- Serve as a validation subject matter expert by providing technical guidance on process validation, cleaning validation, equipment qualification, computerized systems validation, and data integrity practices.
- Support change control and quality system activities by assessing validation impacts, contributing to investigations, and leading resolution of validation-related non-conformances and corrective actions.
Requirements
- Bachelor's degree in engineering, Chemistry, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline.
- Nice to have: pharmaceutical manufacturing operations
- Nice to have: liquid processing systems
- Nice to have: Health Canada regulations
- Nice to have: TrackWise Change Management
Skills
validation experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environmentequipment qualificationprocess validationcleaning validationcomputerized systems validationdata integrityGMP regulationsPICsISO standardsregulatory compliancestatistical techniquesMinitabStatistical Process Control (SPC)data analysis methodologiesTrackWiseERP systems