Duties
Assist in the development, execution and approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviation. Ensure compliance with in-house specifications, standards and procedures and implementing industry best practices. Participate in the creation of Design Specifications, User Requirements and Functional Specification Requirements. Perform installation, operational and performance qualification testing of equipment, including development of protocols, execution and report writing. Represent the validation department in multi-disciplinary teams focused on production and laboratory equipment and activities (commissioning, validation and computerized system validation). Perform investigations and implement corrective actions related to CAPAs and deviations. Coordinate the investigation, impact assessment and resolution for all deviated equipment or processes discovered upon validation or re-validation. Provide technical assessments on change controls, deviations and investigations. Communicate with clients and across departments to provide understanding of validation activities. Support process development activities. Perform factory and site acceptance testing of equipment, including development of protocols, execution and report writing. Create and manage metrics to support trending and management review. Perform temperature mapping, equipment, steam sterilization and cleaning validation. Manage contractors performing equipment and system qualifications. Support the execution of engineering projects. Develop competencies in core process technologies and maintain knowledge of equipment and manufacturing technology changes. Support continuous improvement projects and activities. Work with subject matter experts (SME) to implement and/optimize key validation and quality initiatives. Conduct business in a responsible manner that complies with all state, OSHA and HIPAA regulations. Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements.
Requirements
Master's degree in Mechanical or Industrial Engineering or related scientific field (or foreign degree equivalent). Demonstrated ability with validation engineering in a regulated industry; Demonstrated ability with global regulatory requirements for validation, including Electronic Records, Electronic Signatures (Part 11 and Annex 11) and GAMP5 guidelines; Demonstrated ability with the System Lifecycle Management process; Demonstrated ability with engineering methods, process controls and manufacturing systems; Demonstrated ability with data analysis, statistics and applied mathematics; Demonstrated ability with design techniques, principles, tools and instruments involved in the production and use of precision technical plans, blueprints, drawings, and models; Demonstrated ability with Microsoft Office suite (Excel, Word, Outlook). Aforementioned ability may be gained professionally or academically (coursework, projects, internships.
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