Validation Specialist

Overview

G.W. Seier founded Vita Health Products in Winnipeg, Manitoba in 1936. Since then, the company has grown from a small mail-order operation selling herbs and patented medicines into one of Canada’s foremost suppliers of over the counter (OTC) pharmaceutical products and natural health products. IVC Vita Health Products is based in Winnipeg and located in the St. Boniface industrial park. It is a vertically integrated manufacturer, marketer, and distributor of a broad line of high-quality nutritional supplements and over the counter medications throughout Canada, with over 260,000 square feet of manufacturing, packaging, and distribution facilities.

IVC Vita Health has a long and proven track record of success and continues to demonstrate strong results with consistent growth. IVC Vita Health is part of the IVC Nutrition Corporation of Companies.

Our benefits package includes a comprehensive set of offerings to attract and retain top talent.

• Competitive salary and performance-based annual bonuses.
• Company paid health, dental, and vision insurance.
• Retirement savings plan with employer matching.
• 7 Paid Personal Leave Days per year.
• Professional development opportunities and tuition reimbursement.
• Employee assistance programs for mental health and well-being.
• Company-sponsored social events and team-building activities.

Join us at IVC Vita Health and be part of a team that values your contributions and invests in your success. We are committed to creating a workplace where diversity is celebrated, and every team member can thrive both personally and professionally.

Under the direction of the QA Validation Manager, the Validation Specialist is responsible for supporting and maintaining the site Validation Program at IVC Vita Health. This role oversees validation and qualification activities related to equipment, cleaning processes, utilities, and computerized systems to ensure compliance with GMP and regulatory requirements. The Validation Specialist plays a critical role in ensuring product quality, safety, efficacy, and data integrity by executing validation activities, supporting continuous improvement initiatives, and collaborating cross-functionally with internal departments and external vendors.

• Develop, execute, and maintain validation protocols, reports, and documentation related to equipment qualification, cleaning validation, utilities, and computerized system validation (CSV).
• Support the QA Validation Manager in coordinating validation projects and collaborating with cross-functional departments and external contractors/vendors.
• Maintain and update Validation Master Plans (VMPs) to ensure compliance with GMP, regulatory, and internal quality requirements.
• Assess Change Control requests to determine validation impact, requalification requirements, and associated risks.
• Conduct investigations and support deviation resolution related to validation activities, including identifying root causes and recommending corrective and preventive actions (CAPAs).
• Review calibration, maintenance, and qualification records to ensure equipment and systems remain in a validated state.
• Perform revalidation activities resulting from changes to equipment, software, processes, raw materials, utilities, or manufacturing procedures.
• Support continuous improvement initiatives, including process optimization, equipment upgrades, and implementation of new technologies or software systems.
• Perform data logger calibration activities and prepare temperature mapping and transportation study reports.
• Analyze validation data using statistical and computer-based tools, including generating graphs, trend analyses, and technical summaries.

• Conduct risk assessments, impact assessments, equivalency assessments, and validation gap analyses as required.
• Evaluate equipment and systems through trend analysis, deviations, maintenance history, and change assessments to ensure ongoing compliance and performance.
• Provide training and technical guidance to employees on validation-related procedures and practices.
• Participate in internal and external audits and support regulatory inspections as required.
• Familiarity with FDA, Health Canada, and GMP regulatory requirements is preferred.

• Bachelor’s degree in Science, Engineering, Pharmaceutical Sciences, or a related discipline, or an equivalent combination of education and experience.
• Participation in internal and external audits and support regulatory inspections as required (note: this item appears to duplicate content from other sections and may be streamlined).
• Familiarity with FDA, Health Canada, and GMP regulatory requirements is preferred.

• Strong technical writing, documentation, and communication skills.
• Excellent analytical and critical thinking skills with the ability to troubleshoot and resolve technical issues.
• Strong understanding of validation principles, risk management, and data integrity…