Decommissioning Engineer

Job Description

Amaris Consulting is building a team of Decommissioning Engineers to retire 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.

You’ll decommission the site’s equipment asset by asset, under the direction of the Amaris Decommissioning Lead. The target is to complete and remove all equipment within scope.

Your responsibilities

• Execute the approved decommissioning process for assigned solid dose equipment, including:
• 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
• Walk down each asset, confirm its boundaries, utilities, interfaces and connected systems, and record its condition before work starts.
• Prepare asset-specific decommissioning plans, risk assessments and protocols using site templates.
• Route documents for review and approval.
• Raise and manage change controls for each asset through to closure.
• Verify the cleaning and decontamination of product-contact parts.
• Collect supporting evidence and document residues, issues and deviations.
• Support the retirement of associated computerised systems, including PLCs, HMIs and standalone data systems.
• Manage data and recipe backups, records archiving and audit trail preservation.
• Coordinate with maintenance, EHS and contractors on lockout tagout, utility disconnection and safe equipment removal.
• Update equipment status in SAP or the site CMMS.
• Retire calibration and preventive maintenance plans.
• Prepare the final decommissioning report for each asset, including its final disposition: transfer, resale or scrap.
• Report progress, blockers and hours to the Decommissioning Lead daily or weekly, as agreed.
  
  

Your profile

Required Experience

• Degree or technical diploma in engineering, such as chemical, mechanical, process or automation engineering, or in pharmaceutical sciences.
• At least 3 years of experience in pharmaceutical manufacturing, engineering or validation within a GMP environment.
• Hands-on experience with oral solid dose manufacturing equipment.
• Practical CQV experience, including protocol writing and execution, deviation management and change controls.
• Experience with at least one of the following:
• Equipment decommissioning
• Production line transfer
• Facility shutdown
• Major equipment replacement
• Good understanding of cleaning verification, cross-contamination control and GMP documentation practices, including ALCOA+.
• Working knowledge of Health Canada GMP requirements, including GUI-0001, and FDA 21 CFR Parts 210 and 211.
• Familiarity with lockout tagout and safe work practices on a manufacturing site.
• 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 handling or decommissioning containment equipment used for potent compounds.
• Exposure to computerised system retirement and data integrity requirements under FDA 21 CFR Part 11 and GAMP 5.
• Experience with SAP PM or another CMMS.
• Experience with paperless validation tools, such as Kneat.
• Familiarity with aseptic manufacturing or EU GMP Annex 1, as the site transitions to aseptic liquid filling.
  
  

Expected Compensation Range:

65-90K 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!