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Sr. Computer Systems Validation Specialist

Date: Jan 9, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

Summary

As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Sr 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 Computer Systems Validation Lead, the Sr CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation.  

This includes: 

• Validation Plans

• User Requirements Specifications

• Functional and Design Specifications

• Testing Protocols (IQ/OQ/PQ/UAT)

• Requirements traceability matrices

• Validation Summary Reports

• SOPs

• Change Control Documentation

• Risk assessment reports

Responsibilities

40%

• Participate in 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, deviations, and 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 development and maintenance of CSV and IT related SOPs, work instructions, and forms.

• May represent function on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed

Qualifications

• 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

 

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 GxP regulated environment (FDA, EU, MHRA)

• Experience working in a GMP environment is required

• Proven experience developing full validation documentation and testing protocols (IQ/OQ/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 compliance as well as USP, EP, ICH and FDA guidelines


Nearest Major Market: Philadelphia

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