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Computer Systems Validation Specialist- GMP

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Closing date
Dec 16, 2021

View more

Discipline
Physical Sciences, Information Technology
Organization Type
Biotech
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Job Details

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

Describe the essential daily job functions and include % of time spent on each.

% 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

Requirements

  • 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.

Find Us
Website:
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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