About the job
As a CSV Engineer, you will maintain and Improve the Computerized System Validation Management System. You will also manage the CSV process within all production and QC facilities, utilities, and equipment and act as an SME for CSV within Batavia. You will be responsible for the commissioning and qualification hardware and associated software to support Utility/Process equipment. This includes interfaces with networks. Documentation preparation and execution of Commissioning, Qualification, and Verification protocols (CQV) for process equipment CSV will be part of the job, as is the coordination/review of Vendor Automation packages to achieve streamlined CSV.
Maintain and Improve the Computerized System Validation Management System
- Implement, maintain, and improve all procedures required for the computerized system validation management system to define Roles & Responsibilities during the CSV process
- Ensure the validation management system complies with GMP and industry standards
- Manage the CSV process within all production and QC facilities, utilities, and equipment
Manage the CSV process of big projects
- Responsible for writing, reviewing, and approving of all CSV-related documentation
- Responsible for the execution of the CSV activities
- Responsible for documenting, investigating, and resolving CSV-related deviations
- Responsible for writing, reviewing, and approving all CSV-related reports
- Ensure the production and QC facilities, utilities, and equipment comply with data integrity
- Responsible for managing suppliers during the execution of CSV activities by suppliers
- Responsible for review of change controls related to production and QC facilities, utilities, and equipment
SME for CSV within Batavia
- Participate during inspections and audits as SME
- Perform (practical) training
- Advise Operations
- Participate in internal audits
- Education: BSc in relevant science or engineering field
- Experience: At least 5 years within the (bio)pharmaceutical industry.
- Languages: English fluently in both oral and writing.
- Be independent while supporting other team members,
- Ability to multitask and take initiative to accomplish assigned tasks accurately within established timelines,
- Hands-on attitude in a dynamic environment,
- High attention to detail,
- Excellent technical problem-solving and troubleshooting skills,
- CSV experience in process and laboratory equipment – Filling lines, Freeze Dryers / Lyos, vial washers & tunnels, cappers, autoclaves, parts washers, storage vessels, etc. is an advantage,
- Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices,
- Experience working with software/automation validation in a project environment is an advantage,
- Technical understanding of any IT Infrastructure, basic manufacturing execution systems, LIMS, Building Management Systems, Environmental Monitoring Systems, Historian and integration with enterprise systems is an advantage.
You can send your application to Mrs. I. van Aarle, HR Director, email@example.com
No unsolicited assistance from search firms is accepted for this employment opportunity.