Validation Engineer – (#349)
Shorewood Hills, Wisconsin
Expiry Date :
Sat, 17 Apr 2021 23:59:59 GMT
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We are recruiting for a Validation Engineerto support our investment in and on-going operationof ourcGMP, research and development, and productionfacilities in Madison, WI. Youll be workingwith our technical operations group along with other highly talented professionals at FUJIFILM Cellular Dynamics, Inc., the leader in induced Pluripotent Stem Cells (iPSCs) technology. You will oversee all aspects of validation and qualification of facilities, systems, utilities, and equipment to meet FCDI requirements. Plan, coordinate, execute and document all aspects related to validation activities, including management of third parties and liaising with Quality and regulatory bodies. This is an excellent opportunity for qualified individuals looking to apply their technical skills and to expand their professional horizons.
ESSENTIAL JOB FUNCTIONS
* Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
* Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
* Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system on the product quality.
* Perform design review to ensure the equipment is installed and operates according to the User Requirement Specifications.
* Perform commissioning, qualification and validation of the equipment and systems.
* Generate and execute validation protocols (IQ, OQ and PQ) for manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, manufacturing equipment and packaging line equipment.
* Characterize equipment operation processes and define critical process parameters and critical quality attributes.
* Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
* Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes.
* Participate in client and regulatory audits.
* Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results
* Assist with determining impact of change control on qualified process and aseptic operations.
* Maintain a company-wide equipment database for all facilities and equipment under company management.
* Schedule vendors and contractors for validation activities.
* Review and approve vendor/contractor issued documentation.
* Assist with set-up and fit out of lab and supports spaces, as requested.
* Other job functions as assigned.