Description
Validation Engineer with deep experience in Software Quality Assurance and Computer System Validation (CSV). The candidate must have the ability to work in a team composed of validation professionals and on a cross functional project team. This candidate will be a creative, solution-minded thinker that has the ability to quickly adapt in a fast-paced, highly regulated environment.- Experience performing analysis of current business processes to translate development documents into user requirements, and functional design specifications.
- Experience authoring Validation Plans, IQ, System Acceptance Test (SAT) Protocols, SAT Scripts, Trace Matrices, Risk Assessments and Validation Summary Reports for assigned projects.
- Experience in reviewing and approving of System Acceptance Test (SAT) Protocols and SAT Scripts
- Experience in preparation of all validation deliverables for presentation to QA for approval.
- Experience in authoring and reviewing change control documentation for presentation to Change Review Board members.
- Experience in authoring and reviewing protocol deviation documentation and in their resolution and final disposition.
- Outstanding communication skills, both verbal and written.
- Ability to engage, interact and negotiate effectively with IT, QA, validation and business project team members.
- Hands on experience in creating, authoring, reviewing Validation Documents
Strong Computer Software Validation (CSV) experience
Good knowledge of CFR 21 Part 11 - Proficient in use of all Microsoft Office solutions.
- Agile methodology experience a BIG plus
- Education: Minimum requirement is a Bachelors degree in Computer Science or a related discipline.
- 5-8 years experience with information systems design, development, implementation and support, the last 3 of which involve computerized systems validation, preferably in the Life Sciences industry.
This person will work with projects within the Product Development Informatics group supporting Global Product Development Clinical Operations, Biometrics and Clinical Sciences business functions. This role includes working on major cross-functional system initiatives.
He/she will analyze the customer needs, assess risks, perform impact analysis, define solutions, document requirements and functional specifications, work with the development team, develop validation and testing strategies and plans and validation/test summary reports.
He/she will participate in the review of system change requests and enhancements. He/she will be asked to help in creating project plans with regards to planning tasks and timelines related to his/her job assignment.
A good understanding of GLP and GCP regulations and experience in the validation of computer systems used in clinical and non-clinical trials (e.g., LIMS, Clinical Data Management) is desired.
To find out more about Real please visit www.realstaffing.com