- Organize the review of the CSV documents by the QA teams.
- Execute the CSV test and support the CSV timelines.
- Write CSV reports.
- Work in close collaboration with the CSV and CQV lead Engineers.
- Interact closely with Process Engineers, Automation Team (EMR), PM and QA.
- Ensure GAMP5 compliance, follow the ASTM guidelines.
- You hold an engineering diploma in Biotechnology, Bioprocess or Chemical Engineering, or similar.
- You have a Minimum of 3+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects.
- You have Expertise in automation and vertical integration as well as data management under validated computer systems.
- You know planning CQV activities, leading large senior reports.
- You have a proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- You are fluent in English, German highly beneficial.
- Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector
- Having a sustainable job with stability and access to a real collaboration
- Benefit from training with accredited and certified centers
- Having a local management team to support you in the achievement of your missions and in the development of your career
- Being part of a dynamic, committed team with real human values that we live by every day
-
CSV Engineer
vor 3 Tagen
agap2 - HIQ Consulting Basel, Schweiz Employeeagap2 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 ...
-
Csv Project Manager
vor 6 Tagen
ALTOGEN AG Basel, Schweiz**CSV Project Manager** · **COMPANY** · ALTOGEN 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, w ...
-
Csv Project Manager
vor 6 Tagen
ALTOGEN AG Basel, Schweiz**CSV Project Manager** · **COMPANY** · ALTOGEN 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, w ...
-
Project Quality Management Expert
vor 1 Woche
D-ploy Basel, SchweizD-ploy prides itself on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, D-ploy optimizes their customer's IT productivity and contributes to the organizatio ...
-
Global Ot Systems Quality Manager
vor 5 Stunden
Lonza Basel, SchweizSwitzerland, Basel · - Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas tha ...
-
Director Digital Quality
vor 6 Tagen
Panda International Basel, Schweiz**Director Digital Quality**: · **Location** · - Basel, Switzerland · **Business Sector** · - Biotechnology · **Job ref** · - 22276 · **Published** · - about 5 hours ago · **Director Digital Quality** · Are you a professional with expertise in digital quality management within th ...
-
Sample Manager Large Molecules
vor 6 Tagen
We make it Basel, SchweizBeschreibung: · We 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 ...
-
Sample Manager Large Molecules
vor 6 Tagen
We make it GmbH Basel, 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, ...
-
Head of Compliance Engineering
vor 6 Tagen
Thermo Fisher Scientific Lengnau, SchweizThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex a ...
-
CQV Consultant
vor 3 Tagen
headcount AG Basel, Schweiz GanztagsCQV Consultant · As CQV you will ensure the quality and compliance of our clients manufacturing processes. Collaborating closely with cross-functional teams to execute CQV and CSV activities, with a particular emphasis on cleaning validation and CSV for critical systems. · Key Re ...
-
Qc Scientist Ii, Electronic Laboratory Systems
vor 3 Tagen
Thermo Fisher Scientific Lengnau, SchweizThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving co ...
-
Technical QA Manager
vor 1 Woche
Flexsis Basel, SchweizEINFÜHRUNG: · As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for a motivated · Technical QA Manager (m/f/d) · This is a full-time position, with a 12-months duration with possible extension. The earliest start date is as soon as possible. Home Of ...
-
Technical QA Manager
vor 6 Tagen
Talentor Switzerland Basel-Stadt, Schweiz ContractingStart date: As soon as possible · Duration: 1 year/possible extension · Workload: 100% · Location: Basel, on-site · Responsibilities: · QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utili ...
-
Technical QA Manager
vor 1 Woche
Talentor Switzerland Basel-Stadt, Schweiz ContractingGeneral Information: · start date: asap · extension: possible · workplace: Basel · remote: on-site required, home office upon discussion · travel: no · Tasks & Responsibilities: · QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV ...
-
Amaris Consulting Sàrl Basel, Schweiz GanztagsWho are we? · Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an interna ...
-
Qualification- & Validation Engineer (m/w/d)
vor 9 Stunden
Pharmatronic AG Pratteln, SchweizQualification- & Validation Engineer (m/w/d) · Pharmatronic AG · Pratteln · Technische Berufe (Sonstige) · Vollzeit · Die Pharmatronic AG wurde 1985 gegründet und ist Teil der weltweit agierenden Glatt-Gruppe mit 3000 Mitarbeitern. · Wir sind ein auf dem Gebiet der Qualifizierun ...
-
Qualification- & Validation Engineer (m/w/d)
vor 5 Tagen
Pharmatronic AG Schweiz - Pratteln GanztagsDie Pharmatronic AG wurde 1985 gegründet und ist Teil der weltweit agierenden Glatt-Gruppe mit 3000 Mitarbeitern. · Wir sind ein auf dem Gebiet der Qualifizierung & Validierung, CSV & Digitalisierung, Kalibrierung, Automation & IT, Engineering, Projektleitung, Consulting und Rekr ...
-
CQV Engineer
vor 1 Stunde
Pharmatronic AG Schweiz - Pratteln GanztagsCQV Engineer (m/w/d) · Die Pharmatronic AG wurde 1985 gegründet und ist Teil der weltweit agierenden Glatt-Gruppe mit 3000 Mitarbeitern. · Wir sind ein auf dem Gebiet der Qualifizierung & Validierung, CSV & Digitalisierung, Kalibrierung, Automation & IT, Engineering, Projektleitu ...
-
Automation-Engineer (m/w/d)
vor 5 Tagen
Pharmatronic AG Schweiz - Pratteln GanztagsDie Pharmatronic AG wurde 1985 gegründet und ist Teil der weltweit agierenden Glatt-Gruppe mit 3000 Mitarbeitern. · Wir sind ein auf dem Gebiet der Qualifizierung & Validierung, CSV & Digitalisierung, Kalibrierung, Automation & IT, Engineering, Projektleitung, Consulting und Rekr ...
-
Recipe Author Pharmasuite
vor 5 Tagen
Randstad Kaiseraugst, Schweiz FreiberuflerDo you possess extensive experience with Pharmasuite? We are currently seeking a Recipe Author Pharmasuite to provide support for the Manufacturing Execution Systems in the manufacturing division of a leading pharmaceutical and diagnostic company in Switzerland. If you have exper ...
CSV Engineer - Basel, Schweiz - agap2 - HIQ Consulting
Beschreibung
agap2 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 will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.
Tasks
The CSV engineer is in charge of ensuring the validated state of computerized systems on manufacturing site, including laboratory equipment.
Create the requested CSV documents: risk analyses, traceability matrixes, validation protocols.
Requirements
Benefits
Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
Only applications from Swiss and EU citizens will be considered.
Engineering Consulting in the fields of Life Science, Automation, Energy, Railway, Construction with Offices in Zürich, Basel und Lausanne
