The Validation Engineer will be responsible to ensure that validation requirements are met for all existing and new equipment/ facilities/utilities and processes by preparing and executing detailed validation protocols that meet the relevant testing standards and any requirements.
Responsibilities:
? Designs and drafts validation sampling and testing plan/protocols.
? Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
? Resolve technical issues encountered during study execution.
? Track and expedite the review and sign-off of qualification documentation.
? Support execution of validation activities.
? Interact with individuals from different departments to plan, execute, and complete qualification activities.
? Drive the completion of validation efforts according to deadlines.
? Write / guide the writing of departmental procedures required for validation.
? Assist during internal and 3rd party audits with validation requirements.
? Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
? Assist with identifying maintenance and calibration requirements.
? Coordinate suppliers with Validation activities including obtaining quotes from suppliers.
? Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
? Review Validation plans, protocols and SOPs written by other validation team members.
? Manage workload arising from unscheduled events.
? Other duties as assigned by management.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
