Validation Engineer

·Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production

·Performed validation of Quality Control laboratories instruments (with and without computer systems) according to the site’s applicable validation SOPs.

·Authors validation deliverables as required.

·Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner.

·Provide validation expertise and support to the Quality Control laboratories.

·At least 4 years’ experience validating equipment

·At least 2 years’ experience validating laboratory instruments with computer systems

·Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.

·Authors cGMP risk assessments, user requirements and function specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Previous experience with validation of laboratory instrument systems preferred.

·Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

·Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.

·Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.

·Previous experience with PR/CAPA systems preferred.

·Ensures lab instrument’s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies to mitigate the gaps.

·Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.

·Support and assist teammates wherever possible.

·Perform other related duties as assigned or required.

·Quality Laboratories Subject Matter Experts for the respective instruments

·Quality Laboratories System Owners for the respective instruments

·Quality Laboratories System Super Users (if applicable) for the respective instruments

·Instrumentation Team (if applicable) for instrument calibration