Computer Systems Validation Specialist
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable until now.
We don t follow footsteps. We create the path.
As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Computer Systems Validation (CSV) Specialist will be involved in all aspects of computer systems validation and qualification within a GxP regulated environment.
Under the general guidance of the CSV Lead and the direction of Sr. CSV Specialists, the CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation.
This includes:
- Validation Plans
- User Requirements Specifications
- Configuration, Functional, and Design Specifications
- Testing Protocols (IQ/OQ/PQ/UAT)
- Detailed risk assessment reports
- Requirements traceability matrices
- Validation Summary Reports
- SOPs
- Change Control Documentation
Responsibilities
40% Participate/support the planning, development, and implementation of computer systems validation documentation. Review/approve and execute computer systems validation documentation.
30% Initiate and oversee system CSV associated change control requests and associated validation documentation.
20% Facilitate, prepare and execute CSV documents for Technical Operations, QC, QA, R&D, and IT groups as necessary. Ensures schedules, and performance requirements are met
10% Provide input into the support and maintenance of CSV and IT related SOPs, work instructions, and forms. May represent CSV on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed
Requirements
- BS degree in computer-science, Information Systems, Computer Engineering or related field is required.
- A minimum of 5-7 years of experience in computer systems validation within a GMP/GxP regulated environment (FDA, EU, MHRA)
- Experience working in a GMP/GxP environment is required
- Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
- Demonstrated working knowledge of GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems
- Strong working knowledge of GxP/GMP compliance and guidance provided by USP, ASTM, ICH, EU, and FDA.
Competencies
Possess the ability to multitask and work independently or in a team environment with moderate supervision
Possess good interpersonal and strong written/verbal communication skills
Well developed skills in prioritizing, organization and time management
Highly motivated and detail oriented with good organizational skills
Ability to work in a dynamic, fast paced environment with shifting priorities
Estimated Salary: $20 to $28 per hour based on qualifications.
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