As the Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure that validation work is being carried out as per company validation policies & procedures.
Duties / Areas of Responsibility
- Contributing to the preparation and review of the Validation Master Plan.
- Generating validation protocols and reports in accordance with cGMP and customer requirements.
- Execution of protocols for equipment, process, utilities, methods and computerised systems.
- Managing the execution of the equipment/software/process validation as per the MVP and project plan.
- Provide guidance to Junior Validation Engineers.
- Conducting internal projects against internal validation policies and procedures.
- Managing the preparation, review and issuing of validation protocols and reports in accordance with cGMP and customer requirements.
- Generating validation documentation including risk assessments, traceability matrices, and validation reports.
- Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems.
- Working directly with a cross functional team to define inputs and requirements to the MVP.
- Reviewing and managing change control forms for Validation/Compliance implications.
- Conducting Risk Assessments.
- Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical devices.
- Execute test cases per protocol and document the results.
- Participate in the development and review of software requirements.
- Contribute to the design and implementation of software validation processes on projects.
- Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process.
- Provide technical direction and hands-on assistance for testing projects.
- Reviewing vendor validation documentation.
Education / Experience / Skills
- Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
- Over 3-5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry.
- Experience in the validation of equipment and utilities.
- Experience of GxP Computerised Systems.
- Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
- Familiar with the GAMP5 guidelines.
- Excellent communication skills, including ability to advise and influence.
- Excellent attention to detail.
- Excellent understanding of validation concepts and documentation.
- Should be based within a commutable range or else willing to re-locate for 1 year period.
Apply for this position
Please email your C.V, Cover letter & the role you are applying for to firstname.lastname@example.org