CSV Engineer
6 days ago
The Computer System Validation Specialist will ensure all computerized systems used to support GMP operations are appropriately validated and controlled.
Responsibilities:
- Collaborate with Site and Global validation team to build alignment of ES validation expectations.
- Collaborate with ES Project Execution team to ensure the oversite of CSV activities associated with the project.
- Provide support of change management procedures and processes in collaboration with Quality.
- Support of the ES validation strategy/validation master plan in alignment with the Quality Organization.
- Accountable for the preparation, delivery, and execution of CSV owned validation protocols.
- Responsible for the System Development Lifecycle and validated the state of ES owned platforms.
- Ownership of investigations, CAPAs and quality and compliance KPIs.
- Responsible for Data Integrity Assessment execution.
- Responsible for the Document Periodic Review process
- Bachelors in Engineer, Automation or similar field
- 3+ years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and food industries.
- Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk based approach.
- Experience with Automation and MES projects and computer validation methodologies.
- Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ) and CSV inspection readiness preparations and/or directly support regulatory agency inspections.
- Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc.
- Understanding of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring
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