Lab Systems Validation Expert

Our Global Biotechnology client is looking for a Lab Systems Validation Expert who will support the team in a site-wide software rollout project.

DUTIES:

- Support development of validation deliverables, such as Functional Requirements Specification (FRS), Detailed Design Specification.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control.
- Ensure compliance with computerised systems to relevant regulatory requirements (eg cGMP/GLP/GAMP/GALP).
- Review existing SOPs and prepare draft to serve as the framework for future lab software validation projects.
- Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports.
- Prepare validation documentation packages and complete validation of Computerized Laboratory Systems.
- Provide QC Equipment Validation: small-scale lab equipment (filters, incubators etc).
- Implement site-wide software upgrade to Nova Flex 2.
- Improve and upgrade the network filing system; ensure network folders are accessible to all and compliant with all applicable regulations.
- Ensure accuracy and timeliness of software compliance for 2018.

REQUIREMENTS:

- Software Validation Engineer must have 5+ years of experience in Cgmp/QC Lab Instruments validation experience.
- Strong knowledge of validation of QC Lab Instruments and cGMP requirements.
- Applicants must possess an engineering or technical degree from an accredited college or university.

If this sounds like an opportunity for you, please apply now.