Job descriptionAmaris 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.
