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Equipment Validation Engineer

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -012020-26313 Region: Newark Metro Area

Job Description

Position Overview:

The Equipment Validation Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification.

Required Competencies-Knowledge, Skills, and Abilities:

Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry

Familiarity with 21 CFR Part 11 compliance

Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.

Experience executing equipment qualification documents

Ability to interact effectively with laboratory, QA, and Facilities groups

Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously

Education & Experience:

BS degree in Engineering or equivalent

Minimum 5 years of experience in FDA-regulated industry, with 3 year experience in equipment qualification.

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