Coordonnateur Validation - Validation Coordinator (Temporaire, 12 mois)

Haleon•Montreal, QC

1d•Onsite

About The Position

Haleon is seeking a Validation Coordinator to join the Montreal (Saint-Laurent) team. This role is ideal for someone meticulous, motivated by a job well done, and driven by the idea of directly contributing to the reliability of our processes and cleaning methods. As a Validation Coordinator, you will play an essential role at the heart of our operations, responsible for executing validation activities, field monitoring, and documentation quality. If you are looking for a dynamic environment where precision, discipline, and continuous improvement are valued, this opportunity is perfect for you. The Validation Coordinator is responsible for planning, coordinating, and executing activities supporting the cleaning process validation plan and process validation in a GMP-compliant environment. They ensure that equipment cleaning processes are designed and validated to systematically prevent cross-contamination and that residues of previous products and cleaning agents remain below scientifically justified transfer limits (e.g., MACO). They ensure that manufacturing processes consistently produce an acceptable product and are appropriately controlled. The Validation Coordinator executes their responsibilities throughout the validation lifecycle—Design, Validation/Qualification, Continuous Monitoring—and supports Process Performance Qualification (PPQ) and continuous process verification activities.

Requirements

Proficiency in French is required for effective communication and adherence to operational and regulatory standards.
Bachelor's degree in Pharmacy, Chemistry, Chemical/Biological Engineering, or a related discipline.
Minimum of 3 years of demonstrated experience in validation, automation, quality, and compliance within a GMP-regulated manufacturing environment.

Nice To Haves

Proficiency in English is sought for effective communication with regulatory agencies and international colleagues.
Hands-on experience in executing cleaning validation/verification (swabbing and rinsing sampling, method suitability, MACO).
Experience supporting Process Performance Qualification (PPQ)/process validation and data collection for Continuous Process Verification (CPV).

Responsibilities

Execute cleaning validation protocols and verification plans aligned with lifecycle principles (design data, validation/qualification, monitoring).
Perform and coordinate swabbing/rinsing sampling, sample handling, chain-of-custody, and submissions to the laboratory with QC.
Execute hold time studies (dirty hold and clean hold), campaign limit assessment, and verification of CIP/manual cleaning parameters.
Execute PPQ sampling plans, collect process data, and ensure traceability of CPPs and CQAs in protocols and batch records.
Support the implementation and transfer of Continuous Process Verification (CPV), including preparation of control charts, alert/action limits, and data flows with QA/QC/MSAT.
Lead or contribute to deviations related to cleaning or validation execution (e.g., out-of-specification TOC/HPLC results, low recovery rates, visible residues).
Write, execute, and close protocols, sampling plans, risk analyses, and final reports; ensure clear traceability and well-defined acceptance and rejection criteria.
Support the update of controlled documents (SOPs/WIs/forms) to ensure alignment with validated status and the latest requirements.
Coordinate with Production, Engineering, QC, QA, MSAT, and EHS to ensure equipment readiness, calibration status, cleaning supplies, sampling kits, and laboratory capacity.
Prepare audit-ready evidence and act as a Subject Matter Expert (SME) during internal or external inspections related to cleaning validation and process validation execution.