CSV Engineer

CSV Engineer
Voir toutes les offres

CSV Engineer

Asia - Singapore
Ingénierie Industrielle et Life-Science
CDI
9/10/2025
POSTULER

Vos responsabilités

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
  • Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
  • Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert
  • Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
  • Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
  • Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
  • Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
  • Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert
  • Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
  • Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
  • Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Votre profil

This is some text inside of a div block.

Job Requirements:

  • Diploma in Engineering, Biotechnology, Life Science or equivalent
  • Minimum 1 year experience with Emerson DeltaV system - software coding review.
  • Hands-on experience in Validation life cycle of computer systems/ GAMP 5 is a must.
  • Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus
  • Experience in Siemens PLC system is a plus
  • 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
  • Excellent communication skills, both written and verbal

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)

POSTULER
Nos autres offres

Facility Supervisor

Asia - Singapore
CDI
Ingénierie Industrielle et Life-Science

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Supervise facility cleaners, ensuring adherence to cleaning schedules and protocols.
  • Conduct training programs for facility cleaners to ensure proper execution of cleaning procedures.
  • Manage the resources and schedules of facility cleaners to maximize efficiency and maintain compliance.
  • Oversee the team’s performance through regular inspections and provide feedback as necessary
  • Monitor and manage cleaning inventory levels, including cleaning agents, disinfectants, PPE, and equipment.
  • Source and purchase cleaning aids, tools, and production-related items as needed.
  • Raise shopping carts for consumables, manage delivery schedules, and perform service confirmations for the department.
  • Conduct regular audits of cleaning supplies to maintain inventory control and prevent wastage.
  • Provide administrative support to the Bio department, including:
    • New Cleaner onboarding administrative processing.
    • Sourcing and purchase of cleaning aids, tools, production related items
    • Consumables inventory management such as raising shopping cart, goods delivery schedule.
    • Perform service confirmation for the department.
    • Document update and management; training coordination.
  • Enforce health and safety policies to minimize contamination risk and ensure a safe working environment
  • Conduct safety training for cleaning staff on safe handling practices.
  • Contribute to the promotion of Antaes services on top of assistance provided to client.
Voir l'offre

Compliance Specialist

Asia - Singapore
CDI
Ingénierie Industrielle et Life-Science

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Conduct internal audits and support internal audit CAPAs follow-up (discussion of response) and management of open audit CAPAs
  • Serve as Compliance Partner for inspection readiness for assigned department
  • Support external inspections(logistics and backroom support)
  • Conduct training for data integrity and review documents related to Data Integrity (Audit trail review, Data Integrity Risk Assessment etc)
  • Support for other areas(Quality risk management, Quality Plan, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
  • Contribute to the promotion of Antaes services on top of assistance provided to client
Voir l'offre

Junior DevOps Engineer

Asia - Singapore
CDI
Digital et Systèmes d'Information

Main Responsibilities

  • Design, develop, and maintain software components and specialized utility programs supporting infrastructure and operational needs.
  • Build and maintain automation tools covering infrastructure provisioning, configuration management, and application deployment.
  • Partner with development teams to implement and improve CI/CD pipelines and streamline release processes.
  • Monitor infrastructure and application performance, proactively identifying and resolving issues.
  • Enforce security best practices and ensure alignment with relevant industry standards and compliance requirements.
  • Keep pace with evolving DevOps technologies and contribute to their adoption within the team.
  • Actively support the growth of a strong DevOps culture, improving processes and ways of working over time.
Voir l'offre

Ingénieur Software .NET Core F/H

Suisse - Fribourg
CDI
Digital et Systèmes d'Information

Nous recrutons en CDI un Ingénieur Software .NET Core F/H afin de rejoindre notre pôle d'expertise industrielle dans le cadre d'un projet de grande envergure et longue durée, d'extension des activités de notre partenaire.

 

En tant que Ingénieur Software .NET Core F/H, vos missions seront :

 

  • Digitalisation des processus administratifs d’un service public
  • Participation au développement au sein d’une équipe SCRUM
  • Contribution à l’ingénierie logicielle : du cahier des charges client jusqu’aux spécifications techniques détaillées
  • Développement back-end sur des systèmes complexes
  • Réalisation de revues de code
  • Rédaction et mise en place de tests automatisés
  • Mise en œuvre de l’intégration continue
Voir l'offre

Constructeur Mouvement F/H

Suisse - Vaud
CDI
Ingénierie Industrielle et Life-Science

Nous recrutons en CDI un Constructeur Mouvement F/H afin de rejoindre notre pôle d'expertise industrielle, dans le cadre d'un projet de grande envergure et de longue durée d'extension des activités de notre partenaire.

 

En tant que Constructeur Mouvement F/H, vos missions seront :

 

  • Création de mouvements horlogers, simples ou complexes, couvrant une gamme allant du milieu de gamme au haut de gamme (incluant quantièmes, chronographes, répétitions minutes, tourbillons et concepts innovants).
  • Conception de complications intégrées ou modulaires.
  • Développement de nomenclatures et de dossiers techniques complets, depuis l’analyse jusqu’à la validation finale.
  • Réalisation d’une veille concurrentielle et technologique.
  • Fourniture de support technique, en interne et auprès des partenaires externes.
  • Contribution active à l’amélioration continue des produits.
  • Collaboration étroite avec les différents départements de l’entreprise au sein d’équipes projets.
Voir l'offre
FORMULAIRE DE CANDIDATURE
* champs obligatoires
En soumettant ce formulaire, vous reconnaissez avoir pris connaissance de la politique de confidentialité de notre site web qui inclut vos droits concernant vos données personnelles.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

CSV Engineer

Asia - Singapore
Ingénierie Industrielle et Life-Science
CDI

Vos responsabilités

This is some text inside of a div block.

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
  • Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
  • Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert
  • Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
  • Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
  • Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
  • Any other tasks assigned
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Votre profil

This is some text inside of a div block.

Job Requirements:

  • Diploma in Engineering, Biotechnology, Life Science or equivalent
  • Minimum 1 year experience with Emerson DeltaV system - software coding review.
  • Hands-on experience in Validation life cycle of computer systems/ GAMP 5 is a must.
  • Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus
  • Experience in Siemens PLC system is a plus
  • 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
  • Excellent communication skills, both written and verbal
Our positions are open to people who have been recognized as disabled workers. T&S Group promotes diversity and equality in the workplace. All qualified M/F candidates are considered for employment on an equal basis.

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)