Process Validation Expert
vor 4 Monaten
The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.
To evolve in this environment, we are looking for our next Process Validation Expert to ensure the coordination of production troubleshooting and Annex 1 project related.
You will be responsible for:
- Contribute to strategy elaboration for Annex 1 remediation in collaboration Process Insight Associate Manager and other departments
- Establish relevant change control proposals related to the projects with Process Insight Associate Manager and integration of the projects in the Site Project Manager roadmap for each products when applicable.
- To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP), Discoverantâ¦
- Assure the timely delivery of required documents (plans, protocols and reportsâ¦) as defined in the project plan
- Ensure that all process support activities are carried out at appropriate compliance levels
- Participate to the establishment of raw material control strategy in relation with suppliers and the MSAT Raw material specialist
Qualifikationen
Who you are:
- Degree in Biotechnology, Process Engineering, Pharmacy or related subject
- Minimum of 3 years of experience in technology transfer, in R&D/Manufacturing environment
- Demonstrated success record in leading project, in process improvements and interaction with other departments
- Sound awareness of bio-pharmaceutical business
- Sound awareness of GMP related issues and Health Authorities' requirements
- Fluent in French and English
-
Process Validation Expert
vor 4 Wochen
Aubonne, Schweiz Randstad VollzeitThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP...
-
Process Validation Expert
vor 4 Monaten
Aubonne, Schweiz Randstad VollzeitThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP...
-
Process Validation Expert
Vor 3 Tagen
Aubonne, Schweiz Randstad (Schweiz) AG VollzeitThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP...
-
Process Validation Specialist
vor 3 Wochen
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob OpportunityWe are seeking a skilled Process Validation Expert to join our team at Randstad. As a key member of our Fill & Finish Department, you will lead and manage all drug product site technical activities at our client site in Aubonne.Your primary responsibilities will include:Coordinating technical transfers, process validation, and commercial...
-
Process Validation Expert
vor 2 Monaten
Aubonne, Schweiz Randstad VollzeitJobdescriptionThe MSAT DP within the Fill & Finish Departmentleads and manages all the Drug Products site technical activitieswithin our client site in Aubonne to ensure the supply of NewBiologic Entities (NBEs) and the business continuity andProduct-Lifecycle activities on legacy products portfolio, incompliance with specifications, registration and...
-
Process Validation Specialist
vor 3 Wochen
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionAs a Process Validation Expert at Randstad, you will play a crucial role in ensuring the quality and compliance of our client's drug products. You will lead and manage technical activities within the Fill & Finish Department to guarantee the supply of New Biologic Entities (NBEs) and business continuity for legacy products.Key...
-
Process Validation Specialist
vor 3 Wochen
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionWe are seeking a highly skilled Process Validation Expert to join our team at Randstad. As a key member of our Fill & Finish Department, you will be responsible for leading and managing all drug product site technical activities to ensure the supply of New Biologic Entities (NBEs) and business continuity for legacy products.Your primary...
-
Cleaning Validation Expert
vor 1 Monat
Aubonne, Schweiz Randstad VollzeitJobdescriptionFor our client Merck in Aubonne, we are currentlylooking for a ‘Cleaning Validation Expert’ until the end of2025.The Cleaning validation within theFill & Finish Department leads and manages all the cleaningvalidation activities within our site to ensure new productionequipment and product implementation, the business continuity...
-
Process Validation Expert
vor 3 Monaten
Aubonne, Schweiz Randstad VollzeitJobdescriptionThe MSAT DP within the Fill & Finish Departmentleads and manages all the Drug Products site technical activitieswithin our client site in Aubonne to ensure the supply of NewBiologic Entities (NBEs) and the business continuity andProduct-Lifecycle activities on legacy products portfolio, incompliance with specifications, registration and...
-
Cleaning Validation Specialist
vor 1 Woche
Aubonne VD, Waadt, Schweiz Randstad VollzeitCleaning Validation ExpertAt Randstad, we are seeking a skilled Cleaning Validation Expert to join our team in Aubonne. This is a 12-month contract opportunity for a professional with expertise in cleaning validation and monitoring activities.Your Role:Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing...
-
Process Validation Expert
vor 2 Wochen
Aubonne, Schweiz Randstad (Schweiz) AG VollzeitThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP...
-
Cleaning Validation Specialist
vor 1 Woche
Aubonne VD, Waadt, Schweiz Randstad VollzeitCleaning Validation ExpertAt Randstad, we are seeking a skilled Cleaning Validation Expert to join our team for a period of 12 months. The successful candidate will be responsible for coordinating cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment.Your Role:Establish and...
-
Cleaning Validation Expert
vor 1 Monat
Aubonne, Schweiz Randstad VollzeitFor our client Merck in Aubonne, we are currently looking for a âCleaning Validation Expertâ until the end of 2025.The Cleaning validation within the Fill & Finish Department leads and manages all the cleaning validation activities within our site to ensure new production equipment and product implementation, the business continuity and...
-
Cleaning Validation Expert
vor 2 Wochen
Aubonne, Schweiz Randstad VollzeitJobdescriptionFor ourclient Merck in Aubonne, we are looking for a Cleaning ValidationExpert (m/f/d) for a period of 12 months. Your Role : Coordinate cleaning validation andmonitoring activities in line with the life cycle of amanufacturing process for biotech manufacturingequipmentEstablish and execute validationprotocols and reports for...
-
Cleaning Validation Specialist
Vor 7 Tagen
Aubonne VD, Waadt, Schweiz Randstad VollzeitCleaning Validation ExpertAt Randstad, we are currently looking for a 'Cleaning Validation Expert' to join our team in Aubonne. The Cleaning validation within the Fill & Finish Department leads and manages all the cleaning validation activities within our site to ensure new production equipment and product implementation, business continuity and...
-
Cleaning Validation Expert Cdmax
vor 2 Monaten
Aubonne, Schweiz Merck Group VollzeitWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...
-
Cleaning Validation Specialist
vor 2 Wochen
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionOur client Merck in Aubonne is seeking a 'Cleaning Validation Expert' until the end of 2025.The Cleaning validation within the Fill & Finish Department leads and manages all the cleaning validation activities within our site to ensure new production equipment and product implementation, business continuity, and Product-Lifecycle activities on...
-
Cleaning Validation Specialist
vor 1 Monat
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionAt Randstad, we are currently seeking a highly skilled Cleaning Validation Expert to join our team in Aubonne. This is a unique opportunity to work with a leading pharmaceutical company, Merck, and contribute to the success of their Fill & Finish Department.About the Role:Develop and implement a cleaning validation strategy that aligns with...
-
QA CSV Engineer
vor 1 Woche
Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionAs a QA CSV Engineer at Randstad, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfilling regulatory requirements and operating as intended.Your primary responsibilities will include:Contributing to CSV strategies, plans, and protocols in accordance with regulatory guidelines...
-
Process and Equipment Data Analyst
vor 2 Wochen
Aubonne VD, Waadt, Schweiz Merck VollzeitUnlock the Power of DataAre you ready to unleash your analytical skills and make a real impact in the pharmaceutical industry? We're seeking a talented Process and Equipment Data Analyst to join our dynamic team at Merck.Your Role:Capture user requirements for equipment data monitoring and scientific data managementSupport the deployment of new releases for...