• Email info@stellaritgroup.com

Computer Systems Validation (CSV) Specialist

Role: Computer Systems Validation (CSV) Specialist
Client: Confidential, a leader in the Pharmaceutical Industry.
Contract: Long Term with 6 month extensions
Location: Open


- The IT Quality Analyst will be responsible for defining, planning, and performing duties that support major system development life cycle activities, including infrastructure qualification review, validation review and change control approval of IT systems.

- In partnership with the team, support activities associated with implementation of a new infrastructure and Computerized Systems (CS) quality system delivering technically robust systems that withstand audits, both internal and external.


- CSV Life Cycle (IQ/OQ/PQ)

- Support the implementation of GxP computerized systems and infrastructure to ensure the approach and execution aligns to industry as well as Biogen expectations.

- Review technical and strategy documents including standard practices, requirements documents, design documents, testing documents, processes and procedures for group / department.

- Review open deviations and CAPA; manage logistics and oversight to ensure timely completion. Assist with technical writing and review of CAPA/deviations as needed.

- Support data integrity implementation and remediation of GxP systems and infrastructure. Assist with periodic review program and schedule, ensuring impacted systems are completed.

- Support various Quality initiatives.

- Approve system life cycle deliverables and activities to ensure that procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support SDLC activities for IT systems.

- Represent IT Quality on assigned IT projects in support of SDLC activities.

- Provide training, and support to IT personnel in their SDLC efforts, to ensure compliance.

- Assist in the completion of Change Control activities according to the company standards.

- Will be essential in maintaining IT Systems that are compliant with regulatory requirements and good business practices.


- Must have hands-on experience supporting implementation of computerized systems (i.e., IT, Manufacturing and QC) within a GxP environment.

- Ability to complete tasks independently and with limited oversight.

- Ability to interpret regulatory guidance (GxP) and company policies and procedures into executable and defendable lifecycle documentation.

- Extensive understanding of respective regulations governing computer systems and controls such as FDAs 21 CFR Part 11, EMAs Annex 11, and MHRAs data integrity guidance.

- Understanding of modern and risk based validation executions.

- Knowledge of underlying infrastructure requirements supporting GxP systems a plus.

- Experience in remediating GxP Systems leveraging risk based methodologies

- 3+ years working in CSV or Quality role supporting computerized systems.

- Background in Lifesciences and/or Pharma/Biotech industries

Stellar IT Solutions is an Equal Opportunity Employer (EOE/AA)

Please email your resume to hr@stellaritgroup.com along with your current location and type of work authorization you have to work in USA.