Reporting to the Snr Validations Engineer the Computer Systems Validation (AE) will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions.
- Coordinates and communicates all testing with affected functional groups and evaluates test results
- Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards
- Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Develop and communicate requirements for quality performance, continuous improvement infrastructure for critical software installations.
- Write validation plans, reports and procedures.
- Execute manual tests for software and system validation. Carefully analyse and document test results.
- Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests.
- Ensure validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate.
- Coordinate and participate in the development, testing and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software.
- Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage.
- Requires a Level 8 or higher degree in an engineering or science discipline with a minimum of 2-3 years of related experience (medical device/pharmaceutical preferred).
- Experience in medical device/pharmaceutical industry in the development and deployment of quality systems, process controls and continuous improvement systems.
- Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA
- Knowledge and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control.
- MS Office competency demonstrated.
- Excellent interpersonal, verbal and written communication skills.
- Adaptable and able to work in a fast paced, dynamic work environment.
- Able to management multiple projects with competing schedules.
- Knowledge of software development methodologies.
- Knowledge of ERP, database systems and architecture.
- Knowledge of PLC programming methodologies and systems.
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