Computer Systems Validation Specialist GLP GCP
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania
- Salary
- Salary not provided
- Closing date
- Dec 15, 2021
View more
- Discipline
- Physical Sciences, Information Technology
- Organization Type
- Biotech
Job Details
- 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
% of Time
Job Function and Description
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
- BS degree in computer-science, Information Systems, Computer Engineering or related field is preferred.
- A minimum of 5 years of relevant work experience with 2 years of 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.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
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.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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