Job Description

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:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field .
• 1-3years of experience in Computer System Validation within the pharmaceutical industry .
• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity regulations.
• Experience validating laboratory and manufacturing systems (LIMS, Empower, TrackWise, SAP, MES, etc.).
• Proven ability to manage multiple validation projects under cGMP compliance.
• Excellent documentation and communication skills.

Preferred Skills:

• Experience with IT Infrastructure Qualification (IQ/OQ) and system lifecycle management.
• Understanding of SDLC methodologies and risk-based validation approaches.
• Familiarity with Quality Management Systems (QMS) and Audit preparation .

Thanks

Suchi

suchi@vastekgroup.com

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.

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