Apotex is a Canadian‑based global health company that improves access to affordable medicines worldwide. With a broad portfolio of generic, biosimilar, cutting-edge branded pharmaceuticals and consumer health products, it serves the Americas and beyond.Job SummaryResponsible for coordination and execution of validation activities within the Manufacturing Science & Technologies (MST) Department, including process and cleaning validation projects, protocol creation, data analysis and reporting.Job ResponsibilitiesWrite, review, and execute all validation risk assessments, protocols, and reports related to process and cleaning validation.Coordinate execution, analyze data, and summarize results for validation protocols.Provide training on validation topics to team members and other departments.Perform technical review of commissioning/validation protocols and peer review of documentation for compliance with cGMP and SOPs.Review and recommend changes to SODs and Production master documents; assess impact viaCCRs and investigations.Communicate and elevate validation deviations, provide troubleshooting assistance, and suggest corrective actions.Support investigations by assembling cross‑functional teams to determine root causes and corrective actions.Provide technical assistance related to validation to customers and internal divisions.Operate and maintain validation equipment,



instruments and consumables.Ensure procedures and documents reflect critical parameters or ranges from validation reports.Communicate project status updates to management using tracking sheets.Work alternate hours/shift schedules as planned business needs require.Perform all work in compliance with the Code of Conduct, Business Ethics and regulatory requirements.Support company values and demonstrate associated behaviors.Adhere to compliance programs and global policies.Perform any other relevant duties as assigned.Job RequirementsEducationBachelor’s degree in science or engineering, or equivalent experience.Knowledge, Skills and AbilitiesHigh level of familiarity with Excel, Word, LIMs, PACE.Proven organizational, problem‑solving, project and time‑management skills.Excellent English speaking and written communication skills.Strong interpersonal skills.ExperienceMinimum of three to five years in Validation; experience in process or cleaning validation, equipment/process qualification is an asset.Experience in the pharmaceutical, food or other chemical processing industry, ideally with exposure to compounding, filling/packaging and cleaning processes for liquid dose products (sterile ophthalmic and nasal products).We offer accommodation for applicants with disabilities as part of the recruitment process. If you are contacted to arrange an interview or testing, please advise us if you require an accommodation.The hiring range for this position is $62,854 – $83,805 CAD per year. The final agreed‑upon salary may vary based on job‑related knowledge, skills and experience.Apotex will use artificial intelligence to screen, select and assess your application for this job.This job posting is for a role that is currently available and vacant at Apotex.#J-18808-Ljbffr

📌 Coordinator, Validation Support - C$62,854 - C$83,805 A Year (Winnipeg)
🏢 APOTEX
📍 Winnipeg