- Perform all functions associated with process-, cleaning- and shipping validation (strategy, planning, writing of plans/ protocols, execution support, reports)
- Author and lead process risk analysis, critical process parameter and critical quality attributes identification and define process control strategy
- Provide data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews (PQR)
- Perform process monitoring (control charts) and statistical process analysis including authoring of continued process verification reports (CPV)
- Represent as Validation Subject Matter Expert (SME) on global project teams and validation councils
- Represent as Validation SME on internal teams (e.g. Deviation and project meetings)
- Participate in internal, customer and regulatory inspections
- Author and support of deviations/ investigations and change controls in manufacturing
- Make recommendations for process changes and sponsor these to the larger process team
- Support Technology Transfer projects as receiving or sending process SME
- Actively drive Operational Excellence and Environmental Health and Safety improvements
- Bachelors degree or higher in Life Sciences, Graduates are very welcome
- Highly autonomous and initiative
- Excellent written (especially technical writing) and verbal communication skills in German and English
- Experience with mid and large-scale process- and cleaning validation in GMP regulated Life Science industry (preferably Biotech) is a plus
- Disposable technology and cell culture experience is a plus
-
Validation Engineer
vor 3 Tagen
Kelly Services Switzerland Neuchâtel, SchweizValidation EngineerPour notre partenaire situé dans le canton de Neuchâtel, Kelly Life Sciences recherche un(e) : Validation Engineer · Vos tâches : · Rédaction et exécution de la qualification des performances CIP, SIP (échantillonnage de surface, cartographie thermique, manipul ...
-
Validation Engineer
vor 1 Woche
Kelly Services Switzerland Neuchâtel, SchweizPour notre partenaire situé dans le canton de Neuchâtel, Kelly Life Sciences recherche un(e) : Validation Engineer · Vos tâches : · Rédaction et exécution de la qualification des performances CIP, SIP (échantillonnage de surface, cartographie thermique, manipulation des bio-indic ...
-
Validation Engineer
vor 5 Tagen
Approach People Recruitment Neuchâtel, SchweizCompany Description · Notre client, leader et pionnier dans le secteur de l'automation est à la recherche de leur prochain Ingénieur Validation. · Rejoignez une entreprise 4.0 qui valorise ses collaborateurs en leur offrant de belles opportunités d'évolution · Job Description · ...
-
Validation Engineer
vor 2 Tagen
Swisslinx Neuenburg, Schweiz GanztagsOn behalf of our client, a leading global pharmaceutical company, we are looking for a Validation Engineer for their site in Neuchatel. Start Date: As soon as possible Location: Neuchatel Work type: On site Workload: 100% Duration: 3 months Extension: Possible Your mission: - Rev ...
-
Agap2 - HIQ Consulting AG Berne, Schweizagap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. · As a consultant, you w ...
-
Validation Engineer H/F
vor 2 Tagen
Flexsis Le Locle, SchweizINTRODUCTION: · Dans le cadre de ses activités de développement, notre client, société industrielle fabricant des machines spéciales, propose pour son site de La Chaux-de-Fonds un/e :Validation Engineer H/F · DESCRIPTION DE LA MISSION: Être le garant du niveau de détail et de la ...
-
Validation Engineer
vor 1 Woche
Randstad Neuchatel, Schweiz TEMPORARYFor our client, an international company based in Neuchâtel, we are looking for a Validation Engineer. · General Information: · Start date: · End date: · Workplace: Neuchâtel · Workload: 100% · Tasks and responsibilities: · Review/pre-approval of SAT protocol, · Review executio ...
-
Validation Engineer
vor 3 Tagen
RM Group AG Neuchâtel, Schweiz GanztagsPharma · Validation Engineer · Switzerland / Contract · Gefällt Ihnen dieser Job? Dann bewerben Sie sich jetzt. · Validation Engineer for a globally operating Neuchatel based company in the pharmaceutical sector. · Your tasks: · Developing validation plans, protocols, and reports ...
-
Validation Engineer
vor 3 Tagen
Talentor Switzerland Neuenburg, Schweiz ContractingMain tasks in new filling area project: · Review/pre-approval of SAT protocol · Review execution of FAT protocol · Writing , execution of IOQ protocol · Writing, execution of performance qualification CIP, SIP (surface sampling, thermal mapping, Bioindicators handling) · Writing ...
-
agap2 - HIQ Consulting Bern, Schweiz CDIagap2 is a dynamic and rapidly growing company and employs more than 9000 people in 14 European countries. With more than 200 employees in Switzerland, we are specialized in Life Science, MedTech, Pharma, BioTech, etc. Our offices in Switzerland are located in Basel, Zürich, and ...
-
agap2 - HIQ Consulting Bern, Schweiz Employeeagap2 is a dynamic and rapidly growing company and employs more than 9000 people in 14 European countries. With more than 200 employees in Switzerland, we are specialized in Life Science, MedTech, Pharma, BioTech, etc. Our offices in Switzerland are located in Basel, Zürich, and ...
-
QA engineering/Validation Expert
vor 2 Tagen
Swisslinx Neuenburg, Schweiz GanztagsOn behalf of our client, a leading global pharmaceutical company, we are looking for a QA engineering/Validation Expert to join the Quality engineering department. Start Date: As soon as possible Location: Neuchatel Work type: Minimum 4 days on site per week. Workload: 100% Durat ...
-
QA Engineering/Validation Expert
vor 1 Tag
Randstad Neuchatel, Schweiz TEMPORARYFor our client, an international pharmaceutical company based in Neuchatel, we are looking for a QA Engineering/Validation Expert. · Background · The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Expert in the frame of ...
-
Cloud Architect Azure
vor 1 Woche
Zühlke Bern, SchweizPermanent · - 80-1'00% · - Bern, Zürich · *** · SOFTWARE ENGINEERING · **Was uns antreibt.** · Als Teil von Zühlke bist du umgeben von Innovation. Wir setzen auf Teamwork, agile Zusammenarbeit und führende Technologien, um die Zukunft zu gestalten und den Status quo in Frage zu s ...
-
Cqv Leads
vor 1 Woche
Project Delivery Partners Bern, SchweizJob Summary · PDP is a number one CQV Project Partner in Switzerland. We have ongoing requirements in Switzerland, and other European locations. We are actively interviewing CQV Leads who have strong knowledge and experience of Upstream / Downstream / Clean /Black Utilities / Sup ...
-
Commissioning and Qualification Lead
vor 3 Stunden
Capgemini Engineering Kanton Bern, Schweiz**About us**: · **World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the re ...
-
Warehouse Operator
vor 3 Tagen
Techfirm Industrial Services Bern, SchweizFor our _**Techfirm Industrial Services**_team, we would like to integrate a · **Warehouse operator (M/W/D)** · ready to join us in Switzerland to take up new challenges together · **WHAT WILL BE YOUR TASKS** · - Performs and documents daily Weigh & Dispense operations and intern ...
-
Quality Assurance Architect 20624-1
vor 3 Tagen
We make it GmbH Bern, SchweizWe make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. · Concentration of placement activities on the core areas of industry, technology, office/administration, ...
-
Manager, Commissioning
vor 3 Stunden
Emergent Biosolutions Bern, SchweizPurpose of this role Ensure efficient qualification processes under the currently applicable requirements and recognized industry best practice Management of the qualification team (Functional and personnel ) · To complement and strengthen our Engineering Department we are lookin ...
-
Analytical Development
vor 5 Tagen
ALTOGEN AG Bern, SchweizALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. · With several years of experience, technical expertise and project coordination, we support our partners throughout all ar ...
Validation Engineer - Thörishaus, Schweiz - Jobcloud
Beschreibung
Position Summary
The role within the Manufacturing, Science and Technology team (MSAT) is responsible for developing a core competency in process-, cleaning- and shipping validation for biotechnological products at late phase clinical trial material production through Process Performance Qualification (PPQ) campaigns, and commercial production, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Support Engineers.
This position incorporates continued process verification on commercial products and supporting technical problem solving. This role may have other validation responsibilities as assigned, but will primarily be in charge of process validation planning, validation execution support, retrieve process data, analysing of the data, look for positive and adverse trends, correlate the findings, solve issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.
What you can expect
Your skills and qualifications
We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile MSAT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package.
Are you interested in joining our mission? We look forward to receiving your application
