Associate Scientist Cleaning Validation
vor 1 Monat
- Jul 14, 2023
- 2 min read
Updated: Sep 5, 2023
The Company
- Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
- Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease
The Role
The position holder will support the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance. This position regularly works cross-functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.
- May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area
- Ensure cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including validation plans, protocols, reports, traceability matrix and summary reports.
- Execute validations for cleaning across the site.
- Coordinate activities interfacing with multiple sites, departments, and external vendors.
- Lead/participate in risk assessments and risk management teams.
- Review change controls and maintenance interventions, evaluate the impact upon qualified systems & validated processes, and document required actions.
- Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements. Participate in the development and maintenance of the local site procedures.
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
- Participates in/leads projects and initiatives and contributes to continuous improvement exercises.
You
Our client is looking for someone who has:
- Degree in Engineering/Technical discipline or experience equivalent.
- Experience (at least 5 years) in validation is required, with a particular focus on cleaning validation for small molecules
- Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
- Good communication skills in English with stakeholders and outside vendor groups
- Automation knowledge advantageous
- Team player: the ability to interact effectively with the team and customers
- Proactively identifies problems and recommends solutions
- Fluent in English and French
***This position has now been filled, please contact be informed of future similar positions***
- Vacancies
The Company
- Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
- Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease
The Role
The position holder will support the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance. This position regularly works cross-functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.
- May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area
- Ensure cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including validation plans, protocols, reports, traceability matrix and summary reports.
- Execute validations for cleaning across the site.
- Coordinate activities interfacing with multiple sites, departments, and external vendors.
- Lead/participate in risk assessments and risk management teams.
- Review change controls and maintenance interventions, evaluate the impact upon qualified systems & validated processes, and document required actions.
- Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements. Participate in the development and maintenance of the local site procedures.
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
- Participates in/leads projects and initiatives and contributes to continuous improvement exercises.
You
Our client is looking for someone who has:
- Degree in Engineering/Technical discipline or experience equivalent.
- Experience (at least 5 years) in validation is required, with a particular focus on cleaning validation for small molecules
- Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
- Good communication skills in English with stakeholders and outside vendor groups
- Automation knowledge advantageous
- Team player: the ability to interact effectively with the team and customers
- Proactively identifies problems and recommends solutions
- Fluent in English and French
***This position has now been filled, please contact be informed of future similar positions***
IT Senior Project Manager - Contract - Neuchatel
Project Manager, Capital Engineering
Global QA Patients Operations Manager - Japanese
-
field Application Scientist
vor 2 Monaten
Schweiz 3Brain Vollzeit3Brain AG Huobstrasse 16 8808 Pfäffikon SZ Schwyz, Switzerland Field Application Scientist Job offer The Company 3Brain AG is a Swiss deep tech company working on cell-electronic interfaces that link biological networks to computers via custom-made semiconductor microchips. Our mission is to empower life scientists to probe intelligent networks,...
-
field Application Scientist
Vor 3 Tagen
Schweiz 3Brain Vollzeit3Brain AGHuobstrasse 168808 Pfäffikon SZSchwyz,SwitzerlandField Application ScientistJob offerThe Company3Brain AG is a Swiss deep tech company working on cell-electronic interfaces that linkbiological networks to computers via custom-made semiconductor microchips. Ourmission is to empower life scientists to probe intelligent networks, acceleratebiomedical...
-
Prinicpal Scientist
vor 3 Wochen
Schweiz Consultants in Science Sàrl VollzeitSep 5, 2023 2 min read Prinicpal Scientist - MS&TWe are looking for a Principal Scientist to lead and/or manage global and strategic projects for our client's Global commercial supply.The Company Our client is a global biopharmaceutical company located near Neuchatel, Switzerland Focused on R&D and delivery of innovative medicines across several...
-
Prinicpal Scientist
vor 1 Monat
Schweiz Consultants in Science Sàrl VollzeitSep 5, 2023 2 min read Prinicpal Scientist - MS&TWe are looking for a Principal Scientist to lead and/or manage global and strategic projects for our client's Global commercial supply.The Company Our client is a global biopharmaceutical company located near Neuchatel, Switzerland Focused on R&D and delivery of innovative medicines across several...
-
Research Associate Validierung
Vor 3 Tagen
Schweiz BÜHLMANN Laboratories AG Vollzeit**BÜHLMANN Laboratories AG** ist eine international tätige und innovative Produktions - und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz in Schönenbuch beschäftigt mehr als 110 Mitarbeitende und ist global aktiv. Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werden weltweit als **in vitro...
-
Research Associate Validierung 100% Für Unsere
Vor 2 Tagen
Schweiz BÜHLMANN Laboratories AG Vollzeit**BÜHLMANN Laboratories AG** ist eine international tätige und innovative Produktions- und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz inSchönenbuch beschäftigt mehr als 110 Mitarbeitende und ist global aktiv.Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werdenweltweit als **in vitro Diagnostika...
-
Consultant en Recrutement Associé
vor 2 Wochen
Schweiz Sparkk VollzeitCritères de l'offre **L'entreprise**: Sparkk Cabinet de recrutement spécialisé dans la recherche et l'évaluation de profils : Scientifiques, Ingénieurs et Manager (fonctions opérationnelles et supports) Recruitment firm specialized in the search and evaluation of profiles: Scientists, Engineers and Managers (operational and support...
-
Consultant en Recrutement Associé
Vor 3 Tagen
Schweiz Sparkk VollzeitCritères de l'offre**L'entreprise**: SparkkCabinet de recrutement spécialisé dans la recherche et l'évaluation de profils : Scientifiques, Ingénieurs et Manager (fonctions opérationnelles et supports)Recruitment firm specialized in the search and evaluation of profiles: Scientists, Engineers and Managers (operational and support functions)Description...
-
Group Leader in Bispecific Antibodies
Vor 3 Tagen
Schweiz Philogen Vollzeit**Location: Zurich - Switzerland** *** **Department: Others** *** **Who we are** Philochem AG is the R&D department of Philogen and it is located in Zurich. Philogen-Siena focuses on product optimisation/production according to GMP standards and on clinical trial investigations. **Job description**: **Responsibilities**: - Isolate novel antibodies...
-
Analytical Op&QC Lab Scientist
Vor 2 Tagen
Schweiz Merck 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 mix of...
-
Data Center Network Technician
vor 2 Wochen
Schweiz Sharp Brains Ltd Vollzeit**Job Title **:Datacenter Network Technician L2 **Responsibilities**: OTDR, LSPM, BER, OSA (Optical Spectrum Analysis) & other fiber testing/cleaning tools (testing, configuration, reporting), provisioning, install cables or optics for new circuits. physical cabling, cable management, northbound cabling, (Fiber/Copper/Power). Support network and server...
-
Invent - Intern - Data Engineering with Life
vor 1 Woche
Schweiz Capgemini Invent Vollzeit**Be part of our journey**: As the digital innovation, design and transformation brand of the Capgemini Group, Capgemini Invent enables CxOs to envision and shape the future of their businesses. Located in nearly 40 studios and more than 60 offices around the world, it comprises a 10,000+ strong team of strategists, data scientists, product and experience...
-
Analytical Op&QC Lab Scientist
vor 2 Wochen
Schweiz Merck 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...
-
Manager Digital Engineering
vor 2 Monaten
Schweiz Capgemini VollzeitBe part of our journey As the digital innovation, design and transformation brand of the Capgemini Group, Capgemini Invent enables CxOs to envision and shape the future of their businesses. Located in nearly 40 studios and more than 60 offices around the world, it comprisesa 10,000+ strong team of strategists, data scientists, product and experience...
-
Consultant (10 Months
vor 2 Wochen
Schweiz UNICEF Vollzeit**Job no**: 567771 **Contract type**: Consultant **Duty Station**: Geneva **Level**: Consultancy **Location**: Switzerland **Categories**: Communication, Partnerships, Fund Raising UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children. To save their lives. To defend their rights. To help them fulfill...
-
Consultant (10 Months
Vor 3 Tagen
Schweiz UNICEF VollzeitJob no: 567771Contract type: ConsultantDuty Station: GenevaLevel: ConsultancyLocation: SwitzerlandCategories: Communication, Partnerships, Fund RaisingUNICEF works in some of the world's toughest places, to reach the world's most disadvantaged children. To save their lives. To defend their rights. To help them fulfill their potential.Across 190 countries and...
