- FR
Validation Specialist
Validation Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
- Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
- Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
- Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
- Develop and configure TrackWise workflows and ensure proper documentation.
- Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
- Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's degree in Computer Science, Life Science, or a related field
- 1-2 years of experience in validation of computer system in the pharmaceutical industry
- Proficiency in Kneat, TrackWise, CAPA, and change control processes.
- Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
- Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
- Strong documentation and technical writing skills.
- 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, in English
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
Engineering Lead - Facilities & Utilities
To join our Life Sciences team in Vaud, we are looking for an Engineering Lead - Facilities & Utilities.
The project:
- Act as the main technical contact for critical utility systems (HVAC, water systems, chillers, process gases, etc.).
- Support investigations and quality/compliance actions (cGMP, GEP, SUVA/ASIT).
- Lead or assist in equipment and plant upgrades or improvements.
- Oversee and approve supplier work.
- Chair engineering team meetings and ensure timely project delivery.
- Avoid overengineering and ensure practical, efficient design.
- Review and approve engineering documents.
- Manage scope, risks, and stakeholders for your workstream.
- Follow the company's project management processes.
CNC Operator F/H
We are recruiting a CNC Operator F/H on a permanent contract to join our center of expertise, as part of a large-scale, long-term project to expand our partner's industrial activities.
As a CNC Operator F/H, your tasks will be :
- Manufacture of complex, high value-added parts.
- Machine preparation and set-up for small and medium production runs, including tool identification and set-up.
- Active contribution to the continuous improvement of production processes.
- Carry out quality control operations on products and tools.
- Carry out first-level maintenance operations on equipment.
- Shift work (2x8).
Créo Mechanical Watch Designer F/H
We are recruiting a Créo F/H Mechanical Watch Designer on a permanent contract to join our Industrial Expertise division, as part of a large-scale, long-term project to expand our partner's industrial activities.
As a Mechanical Watch Designer, your responsibilities will include :
- Transfer and update technical files in the current data management database.
- Draw up complete component and assembly definition files, including mock-ups, geometric drawings and associated data.
- Search archives and legacy systems for existing definitions.
- Check and validate the accuracy of definition data when re-using it.
- Identify and coordinate requirements for geometric analysis, composition, material condition, assembly and marking.
- Propose definition changes and lead technical validation sessions.
- Support remanufacturing projects and manage the necessary adaptations.
- Use management and traceability tools to monitor activities.
- Write technical files in accordance with the processes applied to the components of production watches.
- Contribute to continuous improvement by proposing, communicating and optimizing methodologies.
Créo Mechanical Watch Designer F/H
We are recruiting a Créo F/H Mechanical Watch Designer on a permanent contract to join our Industrial Expertise division, as part of a large-scale, long-term project to expand our partner's industrial activities.
As a Mechanical Watch Designer, your responsibilities will include :
- Transfer and update technical files in the current data management database.
- Draw up complete component and assembly definition files, including mock-ups, geometric drawings and associated data.
- Search archives and legacy systems for existing definitions.
- Check and validate the accuracy of definition data when re-using it.
- Identify and coordinate requirements for geometric analysis, composition, material condition, assembly and marking.
- Propose definition changes and lead technical validation sessions.
- Support remanufacturing projects and manage the necessary adaptations.
- Use management and traceability tools to monitor activities.
- Write technical files in accordance with the processes applied to the components of production watches.
- Contribute to continuous improvement by proposing, communicating and optimizing methodologies.
CQV CSV Specialist
To join our Life sciences team in Vaud, we are looking for a CQV CSV Specialist Consultant.
Your role :
- Represent the department in project meetings.
- Prepare, update, and archive qualification/validation documents (plans, protocols, reports, traceability matrices).
- Organize and execute FAT/SAT/IQ/OQ/PQ tests.
- Coordinate external service providers.
- Draft and manage deviations.
- Contribute to process improvement in qualification/validation activities.
Validation Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
- Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
- Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
- Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
- Develop and configure TrackWise workflows and ensure proper documentation.
- Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
- Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's degree in Computer Science, Life Science, or a related field
- 1-2 years of experience in validation of computer system in the pharmaceutical industry
- Proficiency in Kneat, TrackWise, CAPA, and change control processes.
- Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
- Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
- Strong documentation and technical writing skills.
- 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, in English
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
