Covance is developing a new strategic service line – Immunology & Immunotoxicology (I&I) and we are looking for a Computer System Validation (CSV) Specialist with at least 2 years of life sciences experience for our Greenfield, IN site. The I&I group of Covance is developing so that in the next 10 years, we will be the leader in early phase drug development.
This is a skilled technical role in the Global I&I group and requires a significant understanding of the science, technical assay development and pharmaceutical regulatory framework.
As the CSV Specialist... you will have working knowledge of the instrumentation and work closely with scientific staff to validate according to regulatory compliance and the needs of the global I&I group.
- Responsible for instrument validations within Global I&I in accordance with current Covance guidelines.
- Partner with Global Business Technology (GBT) Computer Systems Validation (CSV)team to ensure current guidelines are met in system validations.
- Coordinate the evaluation and recommendations of new instrumentation across Global I&I to ensure alignment of technologies where possible.
- Point of Contact with relevant companies to obtain details on goods/equipment as required.
- Responsible for introduction, implementation and continuing compliance of any instrumentation when required.
- Assist in the introduction of new techniques, methodologies and relevant procedures in collaboration with the Senior Technical Specialists where required.
- Ensure the Systems Inventory is up to date at all times.
- System Life Cycle Documentation
- Provide, analyse, interpret, report and discuss technical data generated by Clinical Pathology.
- Have a clear understanding of GLP/GCP/SOP’s and their implications for CPS, and to work in strict accordance with them at all times.
- Recommend, implement and report upon cost saving initiatives for processes under jobholder’s local control.To comply with company and departmental safety regulations at all times.