Senior Validation Coordinator

Factors Group of Nutritional Companies•Coquitlam, BC

2d•CA$65,500 - CA$82,000•Onsite

About The Position

The Senior Validation Coordinator is responsible for coordinating and overseeing validation activities within a regulated manufacturing and lab environment. The role ensures compliance with regulatory requirements, approved procedures, and production timelines. The incumbent provides technical direction and functional oversight to validation and lab personnel, supports scheduling and prioritization of validation activities, and ensures alignment with operational objectives overseeing the work of technicians and coordinators.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a closely related science discipline.
GMP industry experience in pharmaceutical or dietary supplement manufacture of solid dosage forms (tablets, capsules, powders), in a hands-on technical/analytical role (5+ years).
Direct, documented validation experience executing IQ, OQ, and PQ protocols in a regulated pharmaceutical or supplement manufacturing environment (3+ years).
Experience authoring, reviewing, or approving validation of master plans, validation protocols, and summary reports in a regulated industry setting.
Excellent oral and written communication skills capable of producing regulatory grade technical documentation independently.
Strong analytical skills with demonstrated ability to interpret complex lab data and draw defensible, risk-based conclusions.
Proven ability to manage multiple concurrent validation projects and prioritize activities to meet regulatory and operational deadlines.
Strong proficiency with MS Office.
Valid BC driver’s license and access to a reliable vehicle.

Nice To Haves

Demonstrated experience supervising or providing work leadership to technical personnel in a regulated manufacturing or lab environment (an asset).
Familiarity with LIMS in a production environment (an asset).
Provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements with at least one of the following regulatory frameworks: health Canada GMP, 21 CFR parts 210/211/11, EudraLex Annex 15, TGA, or GAMP 5 (an asset).

Responsibilities

Execute a variety of validation activities including, but not limited to: Cleaning Validation, Process Validation, Content Uniformity, Equipment Qualification, Computer Systems Validation, and Analytical Method Validation.
Create and maintain process validation and cleaning matrices performance by equipment train.
Use company Quality Management System (QMS) for document creation, revision, review, approval, and retention in compliance with 21 CFR Part 11; provision of guidance to junior personnel on documentation standards.
Support change control process through initiation of change controls (CC) and document change requests (DCR), review of CC for validation impacts, performance of action items, and provision of additional data.
Provide accurate, complete, and cGMP-compliant analysis reports, including result entry in computerized reports or Lab Information Management System (LIMS), in accordance with approved Work Procedures (WP) and Standard Operating Procedures (SOP), Analytical Methods (AM), and current Good Manufacturing Practices (cGMP).
Other duties as assigned.