AutoStream Global are partnering up with multiple global leading pharmaceutical, medical device and biotechnology companies that are looking for multiple Computer System Validation (CSV) Engineers that can be placed in one of their many sites in Ireland and Europe.
- Responsible for authoring Gxp computer validation as well as CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS, and summary reports.
- Provides Quality leadership, direction, and governance for the specific area of responsibility.
- Manages quality-related matters specific to area (Quality System or Quality Program) of responsibility.
- Is responsible for approving appropriate quality-related documents.
- Establishment, maintenance, and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
- Is responsible for providing consulting, training and feedback to site and corporate personnel and projects, and lead compliance to computer system quality standards.
- Maintenance of all aspects of GMP / CSQ compliance for the area(s) of responsibility.
- Provide guidance, review, and approval for all computer related validation documentation.
- Documents resulting from CSVP and other CSQ processes across all site systems, laboratories, process automation and IT.
- As policy is set by the Corporate QA organization, help site consistently interpret and implement the policies across all Computer Systems areas (e.g., IT, Process Automation, Lab Automation).
- Bachelor's degree in engineering or Computer Science.
- Experience with IOQ protocol generation, review, and execution.
- Deep knowledge of regulations and a thorough understanding of GAMP guides, 21 CFR Part 11 etc.
- Excellent communication skills (written and oral).
- Ability to multi-task and handle tasks with competing priorities effectively.
- Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures), global regulatory experience and demonstrated experience interfacing with regulators.
- Excellent collaboration skills and teamwork mindset
- Experience in the biotechnology and/or pharmaceutical industry, (preferably both).
- trouble shooting and problem-solving skills as well as an ability to work through complex problems.