What are the responsibilities and job description for the Computer Systems Engineer position at Novozen Healthcare LLC?
MUST HAVES :
- 1 year of relevant experience in Biopharmaceutical or Pharmaceutical industry
- Previous direct experience in the validation or QA Validation oversight of IT systems.
- Previous of experience with Veeva or other Electronic Document Management Systems
- Experience with computer system validation
- Experience with qualification of lab computerized and instruments
- Must have a solid understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
PLUSSES : Prior QA Validation
DAY TO DAY :
A biotechnology client is seeking a CSV Engineer to sit 100% remote. This individual will be responsible for providing quality oversight support and guidance for qualification and validation activities related to computer system validation. The individual will provide QA Validation support and facilitate the development of validation plans, protocols and summary reports for all stages of the validation of IT systems such as Electronic Document Management Systems. Daily responsibilities include qquality oversight for validation activities related to the implementation of IT systems. Additionally, he / she will collaborate with system and business owners during qualification activities of IT systems. The CSV Engineer must adhere to regulatory guidance, policies, and procedures for qualification, and validation of IT systems. He / She will provide QA Validation support and oversight for the development of user requirements, detailed design specifications, functional and configuration specifications, and requirements traceability matrices. This resource will be reporting into a Senior Manager and will be tasked to provide regular updates directly to her and other management.
