Computer System Validation Engineer

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Job Title : Validation Engineer

Location : Kalamazoo, MI

Contract : Long Term

Overview:

Contractor will be included in all aspects of the Computer Systems Validation (CSV) cycle. Contractor will be responsible to support the implementation of new system/applications as well as to ongoing GxP system projects across the Radius. Contractor should be able to develop all CSV documentation required for a 21 CFR Part 11 validated computer system. Contractor shall utilize knowledge of all phases of Software Project Development Life Cycle and contribute to Analysis, Design, Development, Testing, Deployment and Retirement of Software Applications.

Duties and Responsibilities:

Specific duties include, but may not be limited to:

Review adherence to and implementation of Radius Change Management methodologies.

Draft and define the Validation Bundle including VMP, URS, UAT, SDS, RTM, VSR and Validation Strategy and coordinate with various stakeholders/third party vendors for IQ, OQ and PQ.

Lead the drafting, planning, implementing, and documenting user acceptance testing.

Possess expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

Generate test protocols to validate new or previously validated systems changes/maintenance.

Qualifications

• 6+ years’ experience in a Quality/GxP environment, with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining computer systems within biotech or pharma.

• Bachelor's Degree in Life Sciences

• Proven experience developing validation bundle and test protocols (IQ/OQ/UAT) within the various SDLC phases.

• Demonstrated working knowledge of GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”.

• Familiar with the conceptual differences between CSV and CSA

• Strong working knowledge of GxP compliance specifically 21 CFR Part 11 and Eudralex Annex 11.

• Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.