Job SummaryThe Coordinator, Sterile Validation is responsible for all sterile validation activities at the Apotex Richmond Hill site. The incumbent will work cross‑functionally with Engineering, Production and Quality in the execution of validation and re‑validation of sterilization processes (i.E.Thermal validation, VHP validation), air flow visualization studies, and aseptic process simulations (APS).Job ResponsibilitiesEnsure all sterile validation activities are performed in compliance with corporate policies, FDA, HPFBI, EC, and ICH’s guidelines, including:Thermal (Moist / Dry Heat) and Gaseous (VHP / ETO) ValidationIrradiation (Gamma / E‑Beam) of Primary Packaging ComponentsContainer Closure IntegritySterilizing Filter ValidationAirflow Visualization Studies (Smoke Studies)Filter Validation StudiesGenerate and coordinate the execution of all sterile validation protocols.Complete summary reports for Sterilization Validation.Assess impact of proposed changes to validated production equipment or processes, evaluate and execute requalification and revalidation as required.Prepare Sterilization Process Validation and other reports for regulatory submissions, including responses to deficiencies, comparability protocols,



new submissions and supplements.Operate and maintain equipment/instruments; assist in calibration of equipment/instruments as required.Initiate change controls and update SOPs in the area of expertise.Communicate with suppliers to obtain required technical information.Provide technical guidance and subject‑matter expertise to sterile operations and investigations.Review validation documentation for compliance with cGMP and SOPs.Work in a safe manner collaborating as a team member to achieve all outcomes.Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Workplace policies, and HR policies.All other relevant duties as assigned.Job RequirementsEducationMinimum B.Sc. in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering, or related discipline.Knowledge, Skills and AbilitiesProficiency in Written and Verbal English communication.Knowledge of Excel, Word, other Microsoft Office programs, and validation software packages would be an asset.ExperienceMinimum 3‑5 years of experience in a GMP production environment, sterile manufacturing or validation experience is an asset.CompensationThe hiring range for this position is $63,482 - $105,804 CAD per year. The final agreed‑upon salary may vary based on factors such as job‑related knowledge, skills and experience.EEO StatementAt Apotex we are committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of our recruitment process.#J-18808-Ljbffr

📌 Coordinator, Sterile Validation (Contract Role) - C$63,482 - C$105,804 A Year (Winnipeg)
🏢 APOTEX
📍 Winnipeg