Equipment Validation Engineer
Newark Metro Area, NJ
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.