Decommissioning Lead

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:

• Phase 1: Process remediation

Review and strengthen the existing decommissioning framework, including:

• Validation Master Plan
• SOPs
• Change-control procedures

Identify gaps against Health Canada and FDA GMP expectations. Write or revise the decommissioning SOP and supporting templates. Develop:

• Isolation and disconnection checklists
• Cleaning and decontamination-verification documents

Define a risk-based approach by equipment category, product contact, potency, and system complexity. Build the decommissioning master plan, including:

• Asset inventory
• Resources
• Milestones
• Schedule

Present the revised process to QA and Validation for review and approval.

• Phase 2: Decommissioning execution

Lead the decommissioning of oral solid dose manufacturing equipment, potentially including:

• Dispensing booths
• High-shear and fluid-bed granulators
• Dryers
• Mills
• Tablet presses
• Encapsulators
• Primary packaging lines
• Dust-collection and containment systems

Raise 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/tagout
• Utility disconnection
• Electrical systems
• Compressed air
• Dust extraction
• Physical equipment removal

Document the final disposition of each asset, including transfer, resale, or scrap. Update equipment lists, drawings, the Site Master File, and the Validation Master Plan. Lead the Amaris decommissioning team and track hours against budget. Report project progress, risks, deviations, and decisions to the client on a weekly basis. Coordinate the decommissioning sequence with construction activities for the new aseptic filling capacity.

Required qualifications

• Degree in Chemical, Mechanical, Process Engineering, Pharmaceutical Sciences, or a related discipline.
• At least 8 years of experience in pharmaceutical manufacturing, engineering, validation, CQV, or GMP operations.
• Hands-on experience with oral solid dose processes and equipment, from granulation through packaging.
• At least one end-to-end decommissioning project involving equipment retirement, line shutdown, site exit, or facility repurposing.
• Strong understanding of the CQV lifecycle, including equipment and system retirement.
• Working knowledge of:
• ASTM E2500
• ISPE Commissioning and Qualification guidance
• GAMP 5
• FDA 21 CFR Parts 210 and 211
• FDA 21 CFR Part 11
• Experience writing and approving:
• SOPs
• Protocols
• Change controls
• Final reports
• Knowledge of cleaning validation, cross-contamination control, potent compounds, and data integrity.
• Track record of leading a small team against a fixed schedule and budget.
• Eligible to work in Canada.
• Available to work full-time onsite in Ottawa.

Nice-to-have qualifications

• Experience in a CMO or CDMO environment.
• Experience decommissioning containment equipment used for potent compounds.
• Experience supporting site conversions to sterile or aseptic manufacturing.
• Familiarity with EU GMP Annex 1.
• Experience with SAP PM, CMMS, Kneat, or other paperless validation systems.
• PMP or equivalent project-management certification.

The ideal candidate is comfortable starting independently at a new site, building trust with client stakeholders, and working directly with operators, Maintenance, Engineering, QA, Validation, EHS, Facilities, and contractors. You should be pragmatic, highly organized, comfortable on the shop floor, and able to protect compliance while maintaining a firm project deadline. The client will participate in the selection process, so strong communication, presentation, and stakeholder-management skills are essential.