摘要
About the Role
Major accountabilities:
Responsibilities:
- Work order review
- Validation Periodic reviews of equipment systems
- System user reviews
- Create and revise engineering owned SOP's
- Periodic reviews of engineering owned documents
- Deviation and CAPA ownership and support
- System alarm trending and reporting and any associated investigations
- Perform and conduct risk assessments.
- Equipment KPI metric generation
- Change control ownership and action item ownership
- Audit trail review
- Engineering library management including maintaining the Validation Document Equipment Lifecycle Index
- Site facility drawing updates and management
- Project administration and associated metrics
- Maintain Engineering dashboards
- Manage workload to ensure timely approval of validation testing and documentation
- Support the engineering department during inspections or audits
- Build productive internal/external working relationships
- Manage end-to-end document workflows for all types of engineering documents
- Exercise good judgment within defined procedures and practices to determine appropriate action
- Update and manage all engineering design and project documentation using AutoCAD, Revit, BIM, Navisworks, Etc.
- Maintain and update all engineering specifications, standards, and design information, including building information modeling data
- Other related duties as assigned
Requirements:
- B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 2 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (6 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations in lieu of degree
- Solid foundation in FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility
- Excellent English oral and written communication skills. Strong technical writing ability required
- Experience with full Autodesk CAD suite
- Proficient in Microsoft Word, Excel, PowerPoint, Teams, and Project
- Knowledge of equipment and computerize system validation concepts
Languages :
- English Proficiency
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Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
