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Directeur(rice) Associé(e), Ingénierie de projets / Associate Director, Project Engineering
- Kirkland, Québec, Canada
- Kirkland, Québec, Canada
About
À propos de Jubilant Radiopharma
Chez Jubilant Radiopharma, nous contribuons à améliorer la vie des patients grâce à des solutions novatrices en médecine nucléaire. Nous sommes une équipe engagée, animée par la collaboration, la sécurité, la qualité et le respect. Nous croyons que chaque personne apporte une valeur unique, et nous voulons que chacun puisse s’épanouir pleinement dans un environnement inclusif et accueillant.
Aperçu du rôle
L’Associate Director, Project Engineering joue un rôle clé dans la planification, la conception et la mise en ?uvre de projets d’ingénierie majeurs. Cette personne dirige les projets de conception, d’installation, de mise en service et de qualification d’équipements et de systèmes, tout en assurant la conformité réglementaire et la performance opérationnelle. Le rôle nécessite une solide expertise technique, un leadership collaboratif et la capacité d’influencer plusieurs parties prenantes internes et externes.
Responsabilités principales
Leadership stratégique de projets
- Diriger des projets d’investissement complexes, de la définition de la portée jusqu’à l’état de préparation opérationnelle.
- Assurer la gouvernance de projet, la gestion des risques et l’alignement avec toutes les parties prenantes.
- Collaborer étroitement avec des firmes d’ingénierie, des fabricants d’équipements et des équipes de construction.
- Garantir que les livrables techniques respectent les exigences opérationnelles, réglementaires et d’affaires.
Supervision technique (procédés, équipements, utilités)
- Fournir une expertise technique pour les équipements de procédés, les utilités, les systèmes d’automatisation et les installations.
- Examiner et guider la préparation de la documentation technique (URS, spécifications, P&ID, FAT/SAT, etc.).
- Soutenir les activités d’installation, de mise en service et de qualification pour assurer la conformité GMP.
Gestion d’équipe et des ressources
- Encadrer et développer les spécialistes en ingénierie et le personnel technique.
- Attribuer les ressources nécessaires pour mener les projets à terme.
- Favoriser une culture de sécurité, de partenariat et d’excellence technique.
Gestion du budget, des coûts et des échéanciers
- Élaborer et gérer les budgets et calendriers (CAPEX/OPEX).
- Surveiller les tendances de coûts et recommander des mesures correctives au besoin.
- Assurer la rigueur financière sans compromettre la sécurité ou la conformité GMP.
Approvisionnement et gestion des fournisseurs
- Travailler avec l’approvisionnement pour la sélection, l’achat et la planification des équipements.
- Participer aux visites chez les fournisseurs et aux revues de conception.
- Maintenir des relations solides avec les partenaires externes pour assurer la qualité des livrables.
Conformité GMP et sécurité
- Veiller au respect des exigences réglementaires (FDA, EMA, Santé Canada, Annexe 1, GAMP 5).
- Soutenir la gestion des déviations et des événements qualité liés aux projets.
- Superviser la documentation de conception, de mise en service, de qualification et de clôture de projet.
Gestion des parties prenantes
- Présenter clairement l’information technique aux équipes techniques et non techniques.
- Rendre compte des progrès, des risques et des plans d’atténuation.
- Maintenir un alignement étroit avec les équipes internes clés (Fabrication, Qualité, Chaîne d’approvisionnement, Installations, etc.).
Qualifications
- Baccalauréat en génie mécanique, chimique, industriel ou domaine connexe (exigé).
- Maîtrise en génie ou domaine connexe (atout).
- Désignation professionnelle en génie (P.Eng. ou équivalent) (préférée).
- Lean Six Sigma Green Belt/Black Belt (atout).
- PMP ou certification équivalente (atout).
- Minimum de 10 à 12 ans d’expérience en environnement pharmaceutique, biotechnologique, aseptique ou autre industrie réglementée GMP.
- Expérience avérée en direction de projets majeurs et gestion d’équipes techniques multidisciplinaires.
- Expérience pratique avec :
- Remplissage aseptique sous isolateurs/RABS Grade A
- Systèmes de formulation
- Lyophilisation
- Utilités propres (WFI, vapeur propre, gaz comprimés)
- Expérience avec des firmes d’ingénierie et fabricants d’équipements.
- Connaissance des systèmes ERP (SAP) et des systèmes qualité électroniques (TrackWise, MasterControl) (atout).
- Excellentes compétences en communication, résolution de problèmes et gestion de parties prenantes.
- Capacité à voyager (10–20 %) pour les activités liées au projet.
About Jubilant Radiopharma
At Jubilant Radiopharma, we are committed to improving patient lives through innovative nuclear medicine solutions. Our culture is rooted in collaboration, safety, quality, and respect. We value the unique perspectives each person brings and strive to create an inclusive, welcoming environment where everyone can thrive.
Role Overview
The Associate Director, Project Engineering plays a key role in leading major engineering initiatives. This person oversees the design, installation, commissioning, and qualification of equipment and systems while ensuring compliance and operational performance. The role requires strong technical expertise, collaborative leadership, and the ability to influence internal and external stakeholders.
Key Responsibilities
Strategic Project Leadership
- Lead complex capital projects from scope definition to operational readiness.
- Oversee project governance, risk management, and stakeholder alignment.
- Collaborate with engineering firms, equipment manufacturers, and construction teams.
- Ensure deliverables meet regulatory, operational, and business expectations.
Technical Oversight (Process, Equipment, Utilities)
- Provide technical guidance across process equipment, utilities, automation, and facility systems.
- Review documentation such as URS, specifications, P&IDs, FAT/SAT protocols and design packages.
- Support installation, commissioning, and qualification activities to ensure GMP compliance.
Team & Resource Management
- Lead, mentor, and develop engineering specialists and technical staff.
- Allocate resources and support effective project execution.
- Foster a culture of safety, collaboration, and technical excellence.
Budget, Cost & Schedule Management
- Develop and oversee CAPEX/OPEX budgets and project schedules.
- Monitor cost trends and recommend corrective actions as needed.
- Ensure financial stewardship without compromising safety or compliance.
Procurement & Vendor Management
- Partner with Procurement for equipment purchasing and planning.
- Participate in supplier visits and design reviews.
- Maintain strong relationships with external partners to ensure high-quality deliverables.
GMP Compliance & Safety
- Ensure compliance with regulatory requirements (FDA, EMA, Health Canada, Annex 1, GAMP 5).
- Support deviation management and project-related quality activities.
- Oversee documentation for design reviews, commissioning, qualification, and project closure.
Stakeholder Management
- Communicate technical information clearly to technical and non-technical audiences.
- Provide regular updates on project status, risks, and mitigation plans.
- Maintain alignment across Manufacturing, Quality, Supply Chain, Facilities, and other teams.
Qualifications
- Bachelor’s degree in Mechanical, Chemical, Industrial, or related Engineering field (required).
- Master’s degree in Engineering or related field (asset).
- Professional Engineering designation (P.Eng. or equivalent) (preferred).
- Lean Six Sigma Green Belt/Black Belt (asset).
- PMP or equivalent project leadership certification (asset).
- 10–12 years of experience in pharmaceutical, biotech, sterile manufacturing, or other GMP-regulated environments.
- Proven leadership of large capital projects and cross-functional engineering teams.
- Hands-on experience with:
- Aseptic filling under isolators/RABS Grade A
- Formulation systems
- Lyophilization
- Clean utilities (WFI, clean steam, compressed gases)
- Experience with engineering firms and equipment manufacturers.
- Experience with ERP systems (SAP) and electronic quality systems (TrackWise, MasterControl) (asset).
- Excellent communication, problem-solving, and stakeholder-management skills.
- Ability to travel (10–20%) for project-related activities.
APPLIQUER MAINTENANT
Languages
- French
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