Coordonnateur Validation - Validation Coordinator (Temporaire, 12 mois)

Haleon•Montreal, QC

11d•Onsite

About The Position

Haleon is seeking a Validation Coordinator to join their Montreal (Saint-Laurent) team. This role is crucial for ensuring the reliability of processes and cleaning methods in a manufacturing environment dealing with complex regulatory factors, technical processes, and high-risk activities. The Validation Coordinator will be responsible for executing validation activities, field monitoring, and documentation quality. The position is ideal for someone who values precision, discipline, and continuous improvement in a dynamic environment. The primary objective is to plan, coordinate, and execute activities supporting cleaning process validation and process validation in a GMP-compliant environment, ensuring equipment cleaning processes prevent cross-contamination and residues are within scientifically justified limits. The role also ensures manufacturing processes consistently produce acceptable products and are appropriately controlled throughout the validation lifecycle (Design, Validation/Qualification, Continuous Monitoring), supporting 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 desired for effective communication with regulatory agencies and international colleagues.
Hands-on experience in cleaning validation/verification execution (swabbing and rinsing sampling, method adequacy, 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 lab with QC.
Execute hold time studies (dirty hold and clean hold), campaign limit evaluation, 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 control charting, 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 assessments, 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 state and latest requirements.
Coordinate with Production, Engineering, QC, QA, MSAT, and EHS to ensure equipment readiness, calibration status, cleaning supplies, sampling kits, and lab 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.