Compli Hiring for Validation Engineer at East Greenbush, NY Full Time

• A solid understanding of FDA Validation guidelines GMP and regulatory experience with expertise in process validations
• Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ) Knowledge of specific manufacturing equipment
• Complete appropriate cGMP documentation throughout validation life-cycle
• Executes qualification and validation in compliance to regulatory requirements by/with/as carry out qualification and validation according to the Validation Program. Use test equipment, instruments and methods to produce data for validation.
• Perform data analysis using statistical methods as appropriate to produce conclusions and recommendations for relevant work activities
• Document root cause and corrective/preventive actions of gap found during validation activities Work under minimal supervision.
• Relies on experience and judgement to plan and accomplish assigned goals.
• May periodically assist in orienting, training , assigning and checking the work of lower level employees.

Judgement is required in resolving complex problems based on experience

• Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations Assisting in troubleshooting of process issues, process characterization and root cause investigations Involved in resolving deviations / non-conformances observed during execution of qualification and validation activities.
• Ability to prepare / issue change controls, CAPAs, and investigations
• Ability to maintain gowning requirements as needed to access controlled areas Demonstrated deep technical skills in aseptic manufacturing/process