Validation Engineer

NewAgeSys   •  

Houston, TX

Industry: Biotech/Pharma

  •  

5 - 7 years

Posted 290 days ago

  by    Anuraj KR

This job is no longer available.

Hello,

Hope you are doing good,..!!!

Please let me know your interest in below job openings.

Req#:7660645

Role: Validation Engineer II

Client: Novartis

Location: Houston TX

Duration: 12 Months

Develop and execute software, packaging, and labeling equipment validation protocols. Develop user, functional, and regulatory requirements. Develop test plans and summary reports.

Minimum of 5-7 years experience in medical device or pharma industries, with at least 2 years in labeling systems

Skills:   

Must be familiar with SDLC, CSV life cycle, and documenting commissioning activities (F.A.T. and S.A.T. testing, process, software and equipment acceptance criteria).

Must be able to independently create a User Requirements Specification by interviewing subject matter experts.

Must be able to independently create a Traceability Matrix from the URS and validation protocols.

Must be able to independently create a validation protocol from the User Requirements Specification.

Must be familiar with UDI requirements, medical device /drug labeling requirements, and 21CFR Part 11 requirements.

Must have experience validating manufacturing equipment, including computer controlled systems (PLC, HMI, Allen Bradley) and vision and inspection systems (Cognex).

Packaging and labeling equipment validation experience a plus.

Must be able to learn software, packaging, and labeling equipment in order to create test cases and expected results.

Must be familiar with typical packaging and labeling equipment (label applicators, vision systems, and label template software).

Must be proficient in MS Office applications.

Knowledge of Bartender, .NET, AS400, and SQL a plus.

Education:   

BS in a technical or scientific field.

Appreciate if you could send me your updated resume in word format with also the following details given below for submission process if interested to take it further.

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Birthday: Just MONTH and DAY :

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$80K - 110K