Computer System Validation (CSV) - IT Associate II
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US
Company:
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.
Summary:
The Computer Systems Validation (CSV) - IT Associate II supports the global Quality CSV group by determining validation strategies and writing validation documents. A BS in a related field and 3+ years in validating computer systems in a pharmaceutical environment is required.
Requirements:
Credentials: BS in Engineering, Science, or a related field
Experience: 3+ years experience in qualifying/validating computer systems, including writing IQ, OQ, PQ documents, in a pharmaceutical environment, Experience writing risk assessments, user requirements, SOPs, and work instructions in a GMP, GXP environment, Experience with enterprise systems: QMS, Trackwise, Veeva, and COMET
Job Description:
The Computer Systems Validation (CSV) - IT Associate II role supports the global Quality CSV group including determining validation strategies and writing validation documents. This role also serves as a resource to other Validation Associates and other departments in the organization. This position reports to the Director of CSV Quality & Compliance and is a remote position.
The responsibilities:
- Validation Documentation Support - validation documentation, including Validation Plans, URS (User Requirement Specifications), FRS (Functional Requirement Specifications), Test Scripts (IQ, OQ, PQ), and Validation Reports in compliance with GxP, FDA, EU and other regulatory standards
- Testing and Execution - Support the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Supports - Document test results and deviations, ensuring issues are properly logged and resolved
- Compliance & Regulatory Adherence - Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and company SOPs. And Assist in audits and regulatory inspections by providing required validation documents
- Risk Assessment & Change Control - Participate in risk assessments related to computerized system and Support change control processes, ensuring all system changes are validated properly
- System & Data Integrity - Ensure data integrity principles (ALCOA+) are applied to all validation processes. And Monitor system performance and report compliance issues
- Collaboration & Training - Work with IT, QA, and business teams to understand system requirements and validation needs. And Assist in training users on validated systems and proper documentation practices
- Continuous Improvement to keep up to date with industry best practices in CSV and regulatory changes. And Assist in process improvements for more efficient validation activities
Required qualifications:
- 3+ years experience in qualifying/validating computer systems, including writing IQ, OQ, PQ documents, in a pharmaceutical environment
- Experience writing risk assessments, user requirements, SOPs, and work instructions in a GMP, GXP environment
- Experience with enterprise systems: QMS, Trackwise, Veeva, and COMET
- Minimal domestic travel (10%) to US site/facility
- Knowledge of regulatory standards, including US CFR (FDA regulations) and EMA guidelines application to pharmaceutical manufacturing and quality systems
