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Computer System Validation Engineer (CSV)

Job ID : 33196

Location : West Windsor, NJ

Company Name : Merit Technology Services

Job Type : Full-Time, contract

Industry : Healthcare

Salary : $35000 - $60000  per year

No. of Positions : 10+

Required Skills : SDLC, IQ/OQ protocols, test scripts, FDA, cGMP.

Benefits : Medical Insurance

Job Description :

0-2 years or Freshers can apply 


· Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.

· Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.

· Perform testing of the entire SDLC, including version/change control and new software rollouts.

· Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.

· Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.

· Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.

· Author IQ/OQ protocols for new or used equipment purchased.

· Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.

· Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.

· Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).



· BS in Engineering, Science, or equivalent technical degree.

· 0-2 years experience required

· Excellent written and verbal communication skills; excellent technical writing skills.

· Strong interpersonal skills and the ability to work in a team environment.

· Ability to work effectively in a fast-paced multitasking environment.

· Strong working knowledge of FDA and cGMP regulations and documentation practices.

· Proficient in Microsoft Word, Excel, PowerPoint.

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All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. is not a Consulting Company/Training Company/H1B Sponsor.

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