MSAT Engineer
MSAT Engineer
Vos responsabilités
Job Description:
Technical Leadership & Quality Management:
- Manage technical deviations, CAPAs, and equipment/process troubleshooting.
- Conduct training and serve as SME for technical equipment.
- Perform risk assessments and gap analyses to mitigate quality and business risks.
- Lead root cause analysis sessions for quality deviations and equipment issues, implementing corrective actions.
Process Optimization & Continuous Improvement:
- Identify and implement process improvements to enhance yield, capacity, and cost-efficiency.
- Lead initiatives to reduce process variability and improve robustness, while maintaining compliance.
- Serve as the technical representative for process-related equipment issues.
- Manage start-up efforts for new equipment, software, or processes.
Project Management:
- Oversee projects focused on process optimization, troubleshooting, and new equipment introduction.
- Prepare necessary documentation, including protocols, reports, and risk assessments.
- Participate in design, development, validation strategy, and routine GMP activities.
- Represent MSAT during technical transfers and GMP activities.
Validation Coordination:
- Develop and troubleshoot validation processes, ensuring compliance with SOPs and regulatory guidelines.
- Execute validation studies, including protocol preparation, execution, data analysis, and reporting.
- Participate in audits and improvements to validation programs.
Audit Preparation & Management:
- Support and lead Management Monitoring (MM) audits.
- Participate in IBM audits, corporate, and regulatory inspections, providing expertise as SME.
Environment, Health, Safety, and Wellness:
- Promote and participate in site safety and wellness initiatives.
- Follow safety training and regulations, using PPEs correctly.
- Report unsafe situations and participate in safety inspections.
- The role involves working closely with MSAT Product Stewardship, Process Science & Manufacturing Technology teams, QA validation, and cross-functional teams to ensure smooth operations and continuous improvements in manufacturing processes.
- Maintain comprehensive documentation to support operational activities, investigations, CAPAs, risk assessments, and continuous improvement initiatives. Ensure all actions comply with current Good Manufacturing Practices (cGMPs) and industry standards.
- Contribute to Life Science projects for Antaes Asia clients
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Votre profil
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 4-5 years’ experience in Engineering, pharmaceutical industry
- Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Experience in Ultrafiltration/diafiltration systems is preferred.
- Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
- Equipment and process troubleshooting skills
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
- Experience with product/process development and project management is a plus.
- Lean Sigma/ Green Belt certification is a plus.
- Continuous improvement mindset
- Adherence to safety protocols and global regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
À propos d'Antaes
Créée en 2007, Antaes est une société suisse de conseil en management et technologie classée dans le top 15 des sociétés de conseil en Suisse. Nous comptons plus de 300 ingénieurs expérimentés qui partagent notre passion.
Présents en Suisse, à Singapour, à Hong-Kong et en France, nous accompagnons nos clients suisses, et internationaux en intervenant dans les domaines suivants :
- Conseil en organisation et transformation
- Ingénierie Industrielle
- Management des systèmes d'Information
En rejoignant nos équipes vous découvrirez :
- Une équipe dynamique dans un esprit start-up
- Un accompagnement humain et un suivi de l’évolution de votre carrière
- Des challenges pour contribuer au développement de votre réseau
- Des événements : team building, meet-up, workshop, Winter Event …
-
Une entreprise certifiée @HappyAtWork et ayant une politique RSE engagée (médaille d’or Ecovadis2023)
Investigations Specialist - Biotech
Location : Vaud
Start date : Asap
Workload : 100%, on-site
To join our Life Sciences team in Vaud, we are looking for an Investigations Specialist. You will manage and resolve manufacturing deviations in the Downstream Processing (DSP) area, ensuring timely and compliant investigations within the quality system.
The project :
- Lead deviation investigations using Six Sigma methods (DMAIC, Ishikawa, 5M, etc.).
- Evaluate equipment, product, and material impacts with expert support.
- Identify root causes and define corrective/preventive actions (CAPA).
- Prepare and present investigation reports and action plans.
- Track key performance indicators (deviations and CAPA).
- Facilitate cross-functional workshops when needed.
Ingénieur Sécurité au travail
Lieux : Genève
Date de début : Asap
Occupation du poste : 100%, sur site
Pour rejoindre nos équipes près de Genève, nous recrutons un Ingénieur Santé et Sécurité au travail.
Le projet :
- Mettre en œuvre et suivre la politique santé-sécurité au sein de plusieurs départements.
- Piloter le système de management santé-sécurité (analyses de risques, audits, formation, reporting, plans d’action).
- Apporter votre expertise sécurité dans les projets de construction ou de rénovation.
- Garantir la conformité incendie et coordonner les relations avec les autorités et partenaires (inspection, OCIRT, SUVA, etc.).
- Participer à l’amélioration continue des systèmes de management QSSE.
Chargé de projet industrialisation & environnement
Lieux : Genève
Date de début : Asap
Occupation du poste : 100%, sur site
Pour rejoindre nos équipes à Genève, nous recrutons un Chargé de projet industrialisation & environnement dont la mission principale est de garantir la conformité légale et la réduction des impacts environnementaux dans le cadre des projets d’acquisition d’équipements industriels.
Le projet :
- Piloter l’amélioration continue des cahiers des charges des équipements, en intégrant les exigences environnementales et énergétiques.
- Définir les objectifs et orienter la stratégie de durabilité pour les projets d’acquisition d’équipements industriels sur les sites de production.
- Promouvoir et intégrer les principes de l’écoconception dans le développement des nouveaux équipements.
- Sur les projets prioritaires, assurer le pilotage des objectifs environnementaux, depuis la définition du cahier des charges jusqu’à la qualification industrielle, en mobilisant l’ensemble des parties prenantes.
- Évaluer les concepts techniques, valider les solutions proposées et contribuer à la prise de décision.
- Organiser la capitalisation et la valorisation des données environnementales dans les outils informatiques dédiés.
- Participer aux réseaux internes de compétences et aux groupes transversaux.
- Assurer une communication proactive et claire auprès des différents interlocuteurs.
Automaticien
Pour rejoindre nos équipes près de Fribourg, nous recherchons un Ingénieur Automaticien avec la maitrise de Beckhoff, Siemens, Rockwell.
Le projet :
- Développer, tester et valider des améliorations logicielles pour les machines outils CNC.
- Optimiser les performances des logiciels et rester à la pointe des technologies.
- Collaborer avec d’autres ingénieurs pour intégrer les solutions logicielles.
- Assurer la maintenance des logiciels existants et le support technique aux utilisateurs.
Project Manager – Equipment Design
We are looking for a proactive and detail-oriented Project Manager in Equipment Design to lead the development, design, and implementation of process equipment within a regulated environment. You will oversee technical design activities from concept to qualification, ensuring compliance with engineering standards, project timelines, and GMP requirements.
Your role:
- Lead equipment design projects from feasibility through to commissioning and qualification.
- Coordinate mechanical, automation, and process design activities with internal and external stakeholders.
- Develop and review technical specifications, design documentation, and FAT/SAT protocols.
- Manage supplier relationships, including technical alignment, design reviews, and project follow-up.
- Ensure budget and schedule control across all project phases.
- Oversee change management and risk assessment related to equipment design and modifications.
- Support CQV teams during qualification phases and participate in design improvement workshops.
- Guarantee compliance with GMP, safety, and quality standards for all equipment.
MSAT Engineer
Vos responsabilités
Job Description:
Technical Leadership & Quality Management:
- Manage technical deviations, CAPAs, and equipment/process troubleshooting.
- Conduct training and serve as SME for technical equipment.
- Perform risk assessments and gap analyses to mitigate quality and business risks.
- Lead root cause analysis sessions for quality deviations and equipment issues, implementing corrective actions.
Process Optimization & Continuous Improvement:
- Identify and implement process improvements to enhance yield, capacity, and cost-efficiency.
- Lead initiatives to reduce process variability and improve robustness, while maintaining compliance.
- Serve as the technical representative for process-related equipment issues.
- Manage start-up efforts for new equipment, software, or processes.
Project Management:
- Oversee projects focused on process optimization, troubleshooting, and new equipment introduction.
- Prepare necessary documentation, including protocols, reports, and risk assessments.
- Participate in design, development, validation strategy, and routine GMP activities.
- Represent MSAT during technical transfers and GMP activities.
Validation Coordination:
- Develop and troubleshoot validation processes, ensuring compliance with SOPs and regulatory guidelines.
- Execute validation studies, including protocol preparation, execution, data analysis, and reporting.
- Participate in audits and improvements to validation programs.
Audit Preparation & Management:
- Support and lead Management Monitoring (MM) audits.
- Participate in IBM audits, corporate, and regulatory inspections, providing expertise as SME.
Environment, Health, Safety, and Wellness:
- Promote and participate in site safety and wellness initiatives.
- Follow safety training and regulations, using PPEs correctly.
- Report unsafe situations and participate in safety inspections.
- The role involves working closely with MSAT Product Stewardship, Process Science & Manufacturing Technology teams, QA validation, and cross-functional teams to ensure smooth operations and continuous improvements in manufacturing processes.
- Maintain comprehensive documentation to support operational activities, investigations, CAPAs, risk assessments, and continuous improvement initiatives. Ensure all actions comply with current Good Manufacturing Practices (cGMPs) and industry standards.
- Contribute to Life Science projects for Antaes Asia clients
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Votre profil
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 4-5 years’ experience in Engineering, pharmaceutical industry
- Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Experience in Ultrafiltration/diafiltration systems is preferred.
- Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
- Equipment and process troubleshooting skills
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
- Experience with product/process development and project management is a plus.
- Lean Sigma/ Green Belt certification is a plus.
- Continuous improvement mindset
- Adherence to safety protocols and global regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
À propos d'Antaes
Créée en 2007, Antaes est une société suisse de conseil en management et technologie classée dans le top 15 des sociétés de conseil en Suisse. Nous comptons plus de 300 ingénieurs expérimentés qui partagent notre passion.
Présents en Suisse, à Singapour, à Hong-Kong et en France, nous accompagnons nos clients suisses, et internationaux en intervenant dans les domaines suivants :
- Conseil en organisation et transformation
- Ingénierie Industrielle
- Management des systèmes d'Information
En rejoignant nos équipes vous découvrirez :
- Une équipe dynamique dans un esprit start-up
- Un accompagnement humain et un suivi de l’évolution de votre carrière
- Des challenges pour contribuer au développement de votre réseau
- Des événements : team building, meet-up, workshop, Winter Event …
-
Une entreprise certifiée @HappyAtWork et ayant une politique RSE engagée (médaille d’or Ecovadis2023)
