aiproject managementgmpmes21 cfr part 11computer system validationgamp 5pas xeu gmp annex 11
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
Очень мало
90к-130к CAD/год
150к CAD180к CADмедиана200к CAD
По похожим ролям (50) ~ 180к CAD/год
На СНГ рынке: $3.2к/мес ($2.2к - $4.7к)
59
Средняя вакансия
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Обязанности описаны понятно, а работа даёт профильный опыт в MES-проектах фармацевтического производства, но указанная зарплата заметно ниже ориентира для сопоставимых senior-ролей в управлении проектами.
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Зарплата ниже рынкаКонсалтингПонятные задачиПрофильная сфера
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
MES PAS-X Project Manager (Pharmaceutical Manufacturing/MES): Leading implementation, rollout, upgrade, and enhancement projects for manufacturing execution systems in a regulated pharmaceutical environment with an accent on GMP, validation, batch records, master data, and cross-functional delivery. Focus on coordinating Quality, Manufacturing, IT, vendors, and integration partners while managing risks, testing, change controls, and post-go-live improvements.
Location: Toronto, Canada
Salary: CAD 90,000–130,000 per year; final compensation depends on experience, skills, and qualifications.
Company
hirify.global is an independent technology consulting firm providing technology solutions across Information System & Digital, Telecom, Life Sciences, and Engineering.
What you will do
Lead MES implementation, rollout, upgrade, and enhancement projects from initiation through go-live and post-implementation monitoring.
Own project plans, budgets, risks, dependencies, governance, status reporting, resources, timelines, and stakeholder communication.
Translate operational needs into user requirements with Quality, Manufacturing, IT, software vendors, and integration partners.
Coordinate the digitisation of paper batch records and the creation, review, and approval of master data and recipes.
Oversee system testing, requirements traceability, validation documentation, deviations, change controls, impact assessments, and acceptance against agreed requirements.
Identify process and system improvements after go-live and ensure deliverables meet GMP and computerised system validation requirements.
Requirements
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.
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.
Nice to have
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.
Culture & Benefits
International community with more than 110 nationalities.
Trust-focused environment with opportunities for career progression.
Internal Academy with more than 250 training modules.
Dynamic environment with internal events, afterworks, and team-building activities.
No Canadian work experience is required.
Equal-opportunity and inclusive work environment.
Hiring process
Brief virtual or phone call.
Approximately three interviews, with the number varying by seniority.
Potential case study, role play, technical assessment, or problem-solving scenario.
Application feedback is provided within a maximum of 45 days from application or the latest interview stage.
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