Validation Specialist

IVC Vita Health•Winnipeg, MB

3h•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Science, Engineering, Pharmaceutical Sciences, or a related discipline, or an equivalent combination of education and experience.
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 requirements.
Ability to manage multiple priorities and projects in a fast-paced environment.
Effective project management, organizational, and time management skills.
Collaborative team player with strong interpersonal skills and the ability to work cross-functionally.
Ability to lead meetings, communicate project status, and drive projects to completion within established timelines.
Proficiency with Microsoft Office applications and validation-related software systems.
Experience with statistical analysis and interpretation of validation data.

Nice To Haves

Familiarity with FDA, Health Canada, and GMP regulatory requirements is preferred.
Knowledge of laboratory instrumentation such as HPLC/UPLC systems and Empower software is considered an asset.
Knowledge of calibration practices, environmental monitoring, and temperature mapping is considered an asset.

Responsibilities

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 datalogger 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.