The Computer Systems Validation Engineer will perform computer system validations under the direction of Quality Assurance. The validation activities will include, but are not limited to, developing the strategies for validating systems, preparing validation plans, writing requirements, performing risk assessments, writing protocols, creating traceability matrices, and preparing protocols and validation reports. In addition, the engineer will support those executing validation protocols including exception reporting.
The engineer will be performing validations for a wide range of types of software such as: software used in software development, quality systems, and manufacturing.
• Take responsibility for the validation of computers systems. Coordinate with QA, IT, and user groups as needed
• Perform validations of computer systems in accordance with the company’s risk based approach, including: developing the strategies for validating systems, preparing validation plans, writing requirements, performing risk assessments, writing protocols, creating traceability matrices, and preparing protocols and validation reports.
• Coordinate and supervise users in the execution of the protocols that you have prepared, including the preparation and resolution of deviations
• Maintain all documentation
• Minimum of 8 years in the Diagnostics / Devices / Biotech / Pharmaceutical industry, with at least 6 years direct responsibility for the validation of computer systems used in development, labs, manufacturing, and quality assurance
• Experience with the following is considered to be a plus:
o Validation of automated equipment and instrumentation
o Validation of IT infrastructure
o Process validation
o Software development
o Software quality assurance
• Experience working in a leadership position on validation projects where you were responsible for performing the validation and obtaining and coordination the assistance of others, such as QA, IT, and users
• In-depth experience in software / computer system validations and flexibility in the use of validation methods and techniques is a must.
• In-depth knowledge of validation regulations, guidance documents, industry standards, and methods, and Part 11. Understanding of what is meant by taking a risk-based approach and experience with such approaches.
• Demonstrated ability to influence project teams and individuals on computer validation matters
• Excellent problem solving and analytical skills
• Excellent verbal and written communication skills
• Ability to work independently, follow company policies and procedures, and methods; motivated self-starter; well organized and reliable.
• Ability to also work as a team member
• Commitment to quality; detail and results oriented.
• Knowledge of lab equipment and instrumentation, and validation methods for such items is a plus
• Broad knowledge of quality system regulations, such as QSRs, ISO 13485, ISO 14971, and IEC 62304. Experience with quality assurance in regulated industries is a plus.
• Experience with software development, database management, and IT experience that has provided knowledge of the IT infrastructure and its services are all pluses.