Validation Engineer III
CLINICAL DATA MANAGEMENT
Client is seeking a strong GCP/GLP Validation & Quality Engineer to support validation activities for GCP/GLP computer systems in Product Development.
- General requirements : LIMS, Sharepoint etc.
- Make sure that the applicable regulations, guidelines and internal procedures related to validation of GCP/GLP computer systems are followed and applied during all stages of the defined software development life cycle (SDLC)
- Provide guidance on testing, validation and documentation to project managers, IT project teams, and database administrators.
- Review and approve SDLC documentation.
- Collaborate with other Systems Specialists, and assist in resolving technical and project-related issues.
- Bachelor s degree in Computer Science or a related discipline, and at least six years of commercial validation experience in a GxP environment in the biotech or pharmaceutical industry.
- Formal training and proficiency in systems development methodologies and computer systems validation in regulated industries.
- Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 50, 58, 312) used in GxP environment and related FDA guidelines, regulations, as well as ICH GCP guidelines.
- Application of industry guidance and best practices regarding the validation and documentation of computer systems (e.g., GAMP).
- Must be able to manage multiple tasks, be able to work independently, and have strong oral and written communication skills. Customer focus and being a team player are a must.
- The candidate must have a sound understanding of the principles of Computerized Information System (CIS) validation in regulated industries (GAMP, Part 11, FDA guidelines and regulations).
- Knowledge and experience with system/database design and architecture, change control, as well as System Development Life Cycle (SDLC) and Quality Assurance (QA) methodologies is required.
- A good understanding of GLP and GCP regulations and experience in the validation of CIS used in clinical and non-clinical trials (e.g., LIMS, Clinical Data Management) is desired.
- The successful candidate will be responsible for maintaining change control, reviewing validation strategies and providing guidance for testing protocols (IQ/OP/PQ) used in the support of CIS used in clinical and non-clinical trials.
- The candidate will also generate validation deliverables as needed for GLP and GCP projects.
- Minimum 5 years/+ of experience in SQA. Resource needed to review/approve validation deliverables for multiple ongoing projects running in parallel.
- BS in Computer Science preferred.
SOFTWARE DEVELOPMENT LIFE CYCLE