Job Description

Job Description

Job Description

Job Description:

We are seeking a CSV (Computer System Validation) Engineer to support an expansion project at a medical device manufacturing facility. The successful candidate will be responsible for validating new and existing computerized systems to ensure compliance with FDA and global regulatory requirements, including 21 CFR Part 11. This role requires experience in validating equipment, software, and control systems used in a GMP-regulated medical device environment.

Key Responsibilities:

• CSV Activities: Develop and execute validation deliverables including risk assessments, user requirements (URS), validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports for computer systems.
• System Validation: Ensure systems comply with FDA regulations, including 21 CFR Part 11, EU Annex 11, and relevant GAMP 5 guidelines.
• Change Control Support: Participate in change control processes related to system upgrades, configuration changes, and system retirements.
• Documentation: Maintain accurate and compliant validation documentation following Good Documentation Practices (GDP) and internal quality standards.
• Cross-Functional Collaboration: Work with Quality Assurance, IT, Engineering, and Manufacturing to support validation and ensure systems are fit for intended use.
• Audit Support: Support internal and external audits by providing documentation and expert input related to system validation.

Qualifications:

• Experience: 2-5years in Computer System Validation within a medical device or life sciences environment.
• Regulatory Knowledge: In-depth understanding of 21 CFR Part 11, GAMP 5, FDA, and EU regulatory requirements.
• Technical Skills: Experience validating systems such as MES, SCADA, PLCs, LIMS, or ERP in a GMP-regulated setting.
• Documentation Expertise: Strong grasp of GDP and validation lifecycle documentation.
• Problem-Solving: Ability to troubleshoot and resolve system validation issues during project lifecycle phases.
• Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field.

Thanks

Suchi | Recruitment Head

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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