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Urgent! Computer System Validation(CSV) Engineer Job Opening In Jersey City NJ – Now Hiring Vastek, Inc.
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 .
3–5 years 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 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.
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Unlock Your Computer System Potential: Insight & Career Growth Guide
Real-time Computer System Jobs Trends in Jersey City, NJ, United States (Graphical Representation)
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Great news! Vastek, Inc. is currently hiring and seeking a Computer System Validation(CSV) Engineer to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Vastek, Inc. adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Computer System Validation(CSV) Engineer Jobs United States varies, but the pay scale is rated "Standard" in Jersey City NJ. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Computer System Validation(CSV) Engineer typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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