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 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 environment.
• 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.
• Experience supporting a site conversion to sterile or aseptic manufacturing.
• Familiarity with EU GMP Annex 1.
• Experience with SAP PM or another CMMS.
• Experience with paperless validation tools, such as Kneat.
• PMP or equivalent project management certification.

What we’re looking for

You’re comfortable arriving alone at a new site and building trust with the client quickly. You explain technical and compliance requirements clearly to operators, maintenance teams, QA and site leadership.

You keep the process compliant while working to a firm deadline. You’re present on the shop floor, not only behind documents, and you know how to turn issues into clear decisions and actions.

You’ll also need to present confidently to client stakeholders, since the client will meet you before awarding the work.

Expected Compensation Range

70k-120K The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications , in compliance with applicable pay transparency requirements.

Canadian Experience Requirement

No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

Artificial Intelligence (AI) Disclosure

No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

Statement Regarding Job Vacancy

This position is a Job creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline

Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call : Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study : Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.

We look forward to meeting you!