Amaris Consulting is looking for a Decommissioning Lead to manage the retirement of oral solid dose manufacturing equipment at a Canadian pharmaceutical contract-manufacturing site.The facility is transitioning away from solid dose production to focus on aseptic liquid filling. The cleared area will be rebuilt to support additional filling capacity.This role includes two phases:Process remediation.Decommissioning execution.Key responsibilitiesPhase 1: Process remediationReview and strengthen the existing decommissioning framework, including:Validation Master PlanSOPsChange-control proceduresIdentify gaps against Health Canada and FDA GMP expectations.Write or revise the decommissioning SOP and supporting templates.Develop:Isolation and disconnection checklistsCleaning and decontamination-verification documentsDefine a risk-based approach by equipment category, product contact, potency, and system complexity.Build the decommissioning master plan, including:Asset inventoryResourcesMilestonesSchedulePresent the revised process to QA and Validation for review and approval.Phase 2:



Decommissioning executionLead the decommissioning of oral solid dose manufacturing equipment, potentially including:Dispensing boothsHigh-shear and fluid-bed granulatorsDryersMillsTablet pressesEncapsulatorsPrimary packaging linesDust-collection and containment systemsRaise and manage asset-specific change controls.Retire associated calibration, preventive-maintenance, and requalification plans in SAP, CMMS, or similar systems.Oversee cleaning, decontamination, and verification of product-contact equipment.Coordinate the retirement of computerized systems, including PLC, HMI, SCADA, and standalone data systems.Ensure data archiving, records retention, and audit-trail preservation in accordance with data-integrity requirements.Coordinate with Engineering, Maintenance, EHS, Facilities, and contractors on:Lockout/tagoutUtility disconnectionElectrical systemsCompressed airDust extractionPhysical equipment removalDocument the final disposition of each asset, including

📌 Decommissioning Lead (Ottawa)
🏢 Mantu
📍 Ottawa