Computer System Validation Engineer(CSV)

Job Description

Job Description

Job Summary :

We are seeking a skilled Computer System Validation (CSV) Engineer to support validation and compliance activities for GxP computerized systems in a pharmaceutical manufacturing environment. The ideal candidate will ensure systems meet regulatory requirements (FDA, EMA, MHRA) and maintain data integrity throughout the system lifecycle.

Key Responsibilities :

• Develop and execute validation documentation including Validation Plans, URS, Risk Assessments, IQ / OQ / PQ protocols, and Summary Reports in accordance with GAMP 5 and company procedures.
• Perform validation of GxP systems such as LIMS, ERP, SCADA, PLCs, and laboratory / production software applications.
• Ensure compliance with 21 CFR Part 11 , Annex 11 , and Data Integrity principles.
• Review vendor documentation, participate in vendor qualification, and conduct User Acceptance Testing (UAT) .
• Support implementation, change control, and periodic review of validated systems.
• Collaborate with Quality Assurance, IT, and Manufacturing teams to maintain system compliance.
• Prepare and support internal and external audits related to computerized systems.
• Maintain validation traceability matrices and ensure controlled documentation practices.

Qualifications & Experience :

Preferred Skills :

Thanks

Suchi

suchi@vastekgroup.com

Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.