MES PAS-X Project manager

Amaris Consulting | Part of Mantu; Toronto; On-site; CAD 90,000 - 130,000; Full time

Job summary

Amaris Consulting is seeking an MES Project Manager to drive a major pharmaceutical MES program in Canada, coordinating Quality, Manufacturing, IT, and external partners to move from initiation to go-live and post-implementation monitoring.

You’ll oversee budgets, planning, risks, and stakeholder communication, with experience in PAS-X or similar MES platforms being a strong advantage.

Qualifications

• 5+ years of experience in life sciences or a regulated manufacturing environment.
• Delivery experience with MES projects or digital/software projects in pharmaceutical manufacturing.
• Project management covering budgets, resources, timelines, risks, and cross-functional teams.
• Familiarity with GMP and computerised system validation.

Responsibilities

• Lead MES implementation, rollout, upgrade, and enhancement projects from initiation through go-live and post-implementation monitoring.
• Own the project plan, budget, risks, dependencies, governance, and status reporting for site leadership.
• Translate operational needs into clear user requirements with Quality, Manufacturing, and technical teams.
• Coordinate digitisation of paper batch records and master data/recipes management.
• Oversee system testing for new use cases and follow up on deviations after go-live.
• Ensure project deliverables meet GMP and computerised system validation requirements in collaboration with Validation and Quality teams.
• Coordinate risk assessments, test strategies, requirements traceability, and validation documentation.
• Manage change controls and impact assessments for MES changes with stakeholders.
• Coordinate activities with software vendors and integration partners and review deliverables for acceptance against requirements.
• Identify process and system improvements after go-live.

Skills

MES projects

Life sciences

Regulated manufacturing

Project management

GMP knowledge

Education

Bachelor's degree in engineering or life sciences

Tools

PAS-X by Körber

Job description

Job Description

Amaris Consulting is looking for an MES Project Manager to support a major pharmaceutical manufacturer in expanding and improving its manufacturing execution system across several production areas. You’ll manage digital manufacturing projects in a regulated environment, taking ownership of scope, planning, delivery, risks, and stakeholder communication. You’ll work closely with Quality, Manufacturing, IT, software vendors, and integration partners to move projects from initiation through go-live and post-implementation monitoring. Experience with PAS-X by Körber is a strong advantage. We’ll also consider candidates with experience on other MES platforms.

Your Responsibilities

• Lead MES implementation, rollout, upgrade, and enhancement projects from project initiation through go-live and post-implementation monitoring.
• Own the project plan, budget, risks, dependencies, governance, and status reporting for site leadership.
• Work with Quality, Manufacturing, and technical teams to translate operational needs into clear user requirements.
• Coordinate the digitisation of paper batch records.
• Manage the creation, review, and approval of master data and recipes.
• Oversee system testing for new use cases and follow up on deviations after go-live.
• Work with Validation and Quality teams to ensure project deliverables meet GMP and computerised system validation requirements.
• Coordinate risk assessments, test strategies, requirements traceability, and validation documentation.
• Manage change controls and impact assessments for MES changes.
• Coordinate activities with software vendors and integration partners.
• Review deliverables and manage acceptance against agreed requirements.
• Identify process and system improvements after go-live.

What You Bring

• At least 5 years of experience in life sciences or another regulated manufacturing environment.
• Experience delivering MES projects, or digital and software projects within pharmaceutical manufacturing.
• Project management experience covering budgets, resources, timelines, risks, and cross-functional teams.
• Working knowledge of GMP and computerised system validation.
• Familiarity with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
• Strong communication skills and the ability to bring IT, Quality, and Manufacturing stakeholders together.
• A bachelor’s degree in engineering, life sciences, computer science, or a related discipline.
• Professional fluency in English.

Skills That Would Be An Advantage

• Experience delivering projects with PAS-X by Körber.
• Direct experience managing MES projects.
• Knowledge of batch record review, deviations, CAPA, or shop-floor quality operations.
• Experience using SQL, Python, or Power BI to analyse system and process data.
• Experience working in an Agile project environment.
• PMP certification or an equivalent project management qualification.

Expected Compensation Range

90K-130K 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!