Amaris Consulting is looking for a Decommissioning Lead to manage the retirement of oral solid dose manufacturing equipment at a Canadian pharmaceutical contract manufacturer.

The client is closing its solid dose production activities to focus exclusively on aseptic liquid filling. The cleared area will then be rebuilt to expand filling capacity.

The role has 2 phases:

- Phase 1: Review and strengthen the site’s decommissioning process.
- Phase 2: Lead the execution across the solid dose equipment, with the area cleared before the summer shutdown at the end of July 2027.

You’ll be the client’s single point of contact for this scope and the first Amaris consultant on site. The client will meet you during the selection process.

Your responsibilities

Phase 1: Process remediation

- Review the current decommissioning framework, including the validation master plan, SOPs and change control procedures.
- Identify gaps against Health Canada and FDA GMP expectations.
- Write or revise the decommissioning SOP and supporting templates, including:
- Decommissioning plans
- Risk assessments
- Isolation and disconnection checklists
- Cleaning and decontamination verification records
- Final decommissioning reports

- Define a risk-based approach for each equipment category, taking product contact, compound potency and system complexity into account.
- Build the decommissioning master plan, including the asset inventory, sequence of work, dependencies, resources and schedule.
- Make sure the plan supports the July 2027 deadline.
- Guide the revised process through the client’s QA and validation review and approval before execution begins.

Phase 2: Execution





- Lead the decommissioning of solid dose equipment, which may include:
- Dispensing booths
- High-shear and fluid-bed granulators
- Dryers and mills
- Blenders
- Tablet presses and encapsulators
- Coating pans
- Dedusters and metal detectors
- Primary packaging lines
- Dust collection and containment systems

- Raise and manage change controls for each asset.
- Retire related calibration, preventive maintenance and requalification plans in SAP or the site CMMS.
- Oversee the cleaning, decontamination and verification of product-contact equipment before release, including equipment exposed to potent compounds where applicable.
- Coordinate the retirement of associated computerised systems, including PLCs, HMIs, SCADA and standalone data systems.
- Manage data archiving, record retention and audit trail preservation in line with data integrity requirements.
- Work with engineering, maintenance, EHS and facilities teams on:

- Lockout tagout
- Electrical disconnection
- Compressed air and vacuum isolation
- Dust extraction disconnection
- Physical equipment removal by third-party contractors

- 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.




- Plan and lead the Amaris decommissioning team.
- Track hours against the agreed budget.
- Report progress, risks and deviations to the client every week.
- Coordinate the decommissioning sequence with the construction schedule for the new filling capacity.

Your profile

Required Experience

- Degree in engineering, such as chemical, mechanical or process engineering, or in pharmaceutical sciences.
- At least 8 years of experience in pharmaceutical manufacturing, engineering or validation within a GMP setting.
- Hands-on experience with oral solid dose processes and equipment, from granulation through packaging.
- Experience leading at least 1 decommissioning project from start to finish, such as equipment retirement, line shutdown, site exit or facility repurposing.
- Strong understanding of the CQV lifecycle, including the retirement phase.
- Working knowledge of ASTM E2500, the ISPE Commissioning and Qualification guide and GAMP 5.
- Experience writing and approving SOPs, protocols, risk assessments and change controls.
- Knowledge of cleaning validation, cross-contamination control and data integrity principles.
- Working knowledge of Health Canada GMP requirements, including GUI-0001, and FDA 21 CFR Parts 11, 210 and 211.
- Experience leading a small team against a fixed schedule and budget.
- Eligibility to work in Canada.
- Availability to work on site full time.

Nice to have

- Experience in a contract manufacturing environment, such as a CMO or CDMO.
- Experience decommissioning containment equipment used for potent compounds.

📌 Decommissioning Lead (Ottawa)
🏢 Amaris Consulting | Part of Mantu
📍 Ottawa