CSV Engineer
vor 1 Tag
Location: Visp, Switzerland
Role Type: Contract/Full-Time
We are seeking a skilled and motivated CSV (Computer System Validation) Engineer to support assigned projects in Visp. The successful candidate will work closely with cross-functional teams, ensuring the compliance and execution of CSV activities throughout the project lifecycle.
Key Responsibilities:- Develop and manage CSV documents according to company SOPs.
- Execute CSV tests and ensure adherence to project timelines in collaboration with Project Managers and CQV Leads.
- Collaborate with Process Engineers, Automation Teams, and QA to drive a consistent CQV/CSV approach.
- Act as the primary CSV point of contact for assigned systems until handover to the operational team.
- Serve as a subject matter expert (SME) on CQV/CSV standards and practices.
- Participate in system impact assessments as the CSV SME.
- Define appropriate design solutions with EMR and package unit vendors for vertical integration within the project environment.
- Oversee the review, approval, and management of CSV documentation, including FAT and SAT participation.
- Develop and execute test protocols while ensuring quality and regulatory compliance.
- Monitor project compliance with CQV guidelines and identify potential gaps for resolution.
- Represent the CSV function in inspections and audits, as required.
Qualifications:
- Technical degree (Bachelor’s level) in Engineering or Applied Sciences; postgraduate qualifications preferred.
- Minimum of 5+ years’ experience in Commissioning, Qualification, and Validation (CQV), with a focus on CSV.
Experience & Skills:
- Significant experience in automation and vertical integration, with expertise in data management under validated computer systems.
- Strong background in managing complex pharmaceutical projects, ideally within biologics (mammalian, CGT) or chemical manufacturing technologies.
- Extensive experience in the regulated pharmaceutical industry or engineering environments, with proven planning and management of CQV activities.
- Expertise in ISPE GAMP5 and ASTM guidelines, with experience managing large and complex projects.
- Comprehensive knowledge of EMA/FDA-regulated environments, as well as ICH, PIC/S, EU, and US regulatory requirements.
- Experience in people management, including coaching and development of internal and external team members.
- Strong collaboration and influencing skills in a matrix environment.
- Excellent analytical, prioritisation, and decision-making skills.
- Effective oral and written communication skills, with fluency in English and German required (additional languages are an advantage).
- Ability to work independently and as part of a team in a fast-paced environment.
- Willingness and ability to train and support colleagues.
-
CSV Engineer
Vor 5 Tagen
Visp, Schweiz NRL VollzeitBackground:Supporting assigned project(s) in Visp as CSV-Engineer:Create the requested CSV documents according to the client’s SOPs.Execute the CSV tests.Support the CSV timelines with PM & CQV-Lead.Close interaction with Process Engineers, Automation Team (EMR), PM, and QA.Responsibilities:80%Acting as subject matter expert (SME) on following client’s...
-
CSV Global Engineer
Vor 2 Tagen
Visp, Schweiz Lonza VollzeitSupporting assigned project(s) in Visp as CSV-Engineer:Create the requested CSV documents according to Lonza SOP’sExecute the CSV testsSupport the CSV timelines with PM & CQV-LeadClose interaction with Process Engineers, Automation Team (EMR), PM and QAForcing the Lonza CQV/CSV Approach during the entire project.Responsibilities:80%Acting as subject matter...
-
CSV Engineer
Vor 5 Tagen
Visp, Schweiz CTC Resourcing Solutions AG VollzeitOur client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CSV Engineer for a 12 months contract in Visp, Valais area of Switzerland.In this role you will support the assigned project, create the requested CSV documents according to Companies...
-
CSV Engineer
Vor 3 Tagen
Visp, Schweiz Lonza Group Ltd. VollzeitCSV Engineer (80-100%) Biologics (m/f/d)Apply locations CH - Visp time type Full time posted on Posted 5 Days Ago job requisition id R64483Today, 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...
-
Senior CSV Engineer 80-100%
Vor 6 Tagen
Visp, Schweiz public.client.lonza.display.name VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
CSV Engineer
Vor 2 Tagen
Visp, Schweiz Lonza VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
CSV Engineer
Vor 2 Tagen
Visp, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Today, 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 that help businesses to help people. In exchange, we let our people own their...
-
Senior CSV Engineer 80-100%
Vor 4 Tagen
Visp, Schweiz public.client.lonza.display.name VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Senior CSV Engineer 80-100%
Vor 6 Tagen
Visp, Schweiz public.client.lonza.display.name VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Senior CSV Engineer 80-100%
Vor 5 Tagen
Visp, Schweiz public.client.lonza.display.name VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Senior CSV Engineer
Vor 2 Tagen
Visp, Schweiz Lonza VollzeitToday, 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 that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Senior CSV Engineer
Vor 2 Tagen
Visp, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:Location:Job Category:-Job Reference:1308441736d6Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Today, 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...
-
Engineer, Project Engineering
Vor 6 Tagen
Visp, Schweiz public.client.lonza.display.name Vollzeitp>Today, 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 that help businesses to help people. And that’s the kind of work we want to be part of.As a Senior CSV Engineer,...
-
Life Sciences System Validator
vor 4 Stunden
Visp, Schweiz client.lonza.display VollzeitWe are looking for a highly skilled and motivated Senior CSV Engineer to join our team at Lonza. As a key member of our project engineering group, you will be responsible for ensuring the quality and integrity of our computerized systems.About the Job:You will generate and execute validation plans for computerized systems, ensuring compliance with regulatory...
-
Senior Operator/Biotechnologist Ibex® m/f/d
Vor 5 Tagen
Visp, Schweiz Lonza Group Ltd. VollzeitSenior Operator/Biotechnologist Ibex m/f/d page is loaded Senior Operator/Biotechnologist Ibex m/f/d Apply locations CH - Visp time type Full time posted on Posted 30+ Days Ago job requisition id R51110 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s...
-
Automation Engineer
Vor 5 Tagen
Visp, Schweiz Hays VollzeitResponsibilities:Participate in automation projects within a team consisting of Automation Engineers, CQV engineers, and CSV engineers, contributing as an essential member of the DeltaV team.Write code in a DeltaV System.Code testing.Commissioning.Apply Good Manufacturing Procedures (cGMP) principles.Support the definition, execution, and documentation of...
-
Software Maintenance Engineer
Vor 5 Tagen
Visp, Schweiz Coopers Group AG VollzeitOur Team at Coopers Group AG">We are a dynamic team of professionals passionate about delivering high-quality solutions. We believe in fostering a collaborative environment where everyone can grow and develop their skills.">Job Description:">As an Application Support Specialist, you will work closely with our team to ensure the smooth operation of our...
-
Manufacturing Specialist Mammalian
Vor 6 Tagen
Visp, Schweiz Lonza Group Ltd. VollzeitManufacturing Specialist Mammalian (m/f/d) page is loaded Manufacturing Specialist Mammalian (m/f/d) Apply locations CH - Visp time type Full time posted on Posted 30+ Days Ago job requisition id R62739 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s...