Description
One of our key clients, a global leader within pharmaceuticals is looking for a highly experienced Computer System Validation Engineer. Responsible for the day-to-day authoring and execution of Validation activities, working with the broader QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.Key Responsibilities
- Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility.
- Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
- Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ,
- Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
- Interface with the client on Commissioning and Process Sciences teams.
- Support the client Management in Project delivery.
- The role is a lot of the hands on work - writing wrap (close off) around protocols, execution vendor documentation, assessing deviations, traceability matrix generation.
Key Requirements
- Strong background within the Biopharmaceutical/Pharmaceutical/Med Device environment experience
- Experience in Document Preparation and Execution
- Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
- Good technical knowledge of equipment and the concepts of BioTech
If this long term opportunity, paying competitive rates, working with cutting edge technology is of interest, then please contact me immediately.