Computer System Validation Engineer (CSV)
This vacancy has now expired. Please see similar roles below...
Proclinical is partnering with a leading pharmaceutical company to advertise a vacancy for a Computer System Validation (CSV) Engineer position. The organisation develops, manufactures, and markets generic and proprietary ophthalmic products. The CSV Engineer will be responsible for all computer system validation activities to ensure compliance with applicable regulations, including FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. They will provide support for computer validation activities in all company facilities. This job will be based in the company's office in Switzerland.
Job Responsibilities:
- Performing analysis, system design, implementation, and validation of manufacturing systems as they related to 21 CFR Part 11.
- Developing computer system validation user and functional requirements.
- Developing and writing project execution plans.
- Performing risk assessments and reviewing technical packages.
- Writing, executing, and reviewing computer validation protocols.
- Developing computer system validation test documentation and performing data integrity testing.
- Reviewing data presented in final summary reports and ensuring data meets acceptance criteria.
- Revising SOPs and/or training procedures in accordance with harmonisation and quality efforts.
Skills and Requirements:
- A Bachelor's degree, preferably in Computer Science.
- A thorough understanding of industry standards and best practices for computer system validation, such as GAMP and ASTM E2500.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Jay Foster at +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-JF1
#HEOR
Related jobs
Highly Competitive Salary
Maidenhead, England
Proclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.
Highly Competitive Salary
Paris, France
Proclinical is seeking a dedicated and experienced Clinical Research Director to manage the clinical activities of a range of products.
US$200000 - US$250000 per annum + Highly Competitive Salary
Gaithersburg, USA
Proclinical is seeking a dedicated and skilled Pathologist with a focus on cardiovascular, metabolic, and renal disease areas. This is a permanent position located in Gaithersburg, MD.
Highly Competitive
Philadelphia, USA
Proclinical is seeking a Lab Manager for a dynamic and innovative lab. This is a permanent position located in Philadelphia, PA.
Highly Competitive Salary
New York, USA
Proclinical is seeking a dedicated and innovative individual for the role of Managing Director, Medical Education. This is a remote permanent position.
Up to US$185000 per annum + Highly Competitive Salary
San Rafael, USA
Proclinical Staffing is seeking an Associate Director-Global Procurement Managed Services to join a leading biotech company.
Highly Competitive Salary
New York, USA
Proclinical is seeking a dedicated and innovative individual for the role of Medical Writer. This is a remote permanent position.
Highly Competitive
Philadelphia, USA
Proclinical is seeking a dedicated and organized Clinical Research Coordinator. This is a permanent position located in Philadelphia, PA.
Highly Competitive
City of London, England
Proclinical is seeking a dynamic Associate Director Outsourcing Operations - Statistics or Programming position for a remote role anywhere within Europe.
Highly Competitive Salary
San Francisco, USA
Proclinical is seeking a dedicated and innovative Senior Scientist specializing in Preclinical Oncology. This is a permanent position located in South San Francisco, CA.