The Role: Validation Engineer
Job Description
We are seeking a skilled Validation Engineer to join our team. As a Validation Engineer, you will be responsible for reviewing all IOQ documentation generated by C&Q vendors.
You will prepare, execute and summarize reports from the PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility.
This includes filling line, lyophilizers, clean utilities, visual inspection, QC laboratories and warehousing.
You will also support and review documentation from calibration and thermal mapping vendors.
Responsibilities
* Evaluation of validation requirements including areas of new equipment, change controls and new requirements
* Monitoring the status of projects and obtaining updates where required from a validation perspective
* Providing support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings
* Liasing with project managers to ensure project schedules are adhered to
* Assessment of current practices to ensure compliance with cGMP requirements
* Review and implementation of procedures, reports, results etc for compliance
* Review and implementation of both global and AICL, CSV documentation
* Coordination of SDLC Documentation
* Review and approval of all projects validation protocols plant wide
* Review and approval of project change controls
* Providing input into the development of company validation standards
Arcadis | DPS Group is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.