Sr. Validation Engineer
Newark Metro Area, NJ
Snr Validation Engineer - CSV
Knowledge, Skills & Abilities:
Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
* Advanced knowledge of 21 CFR Part 11 compliance*** (candidates should be aware of this if they work in this field) and Data Integrity policy requirements
* Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures.
* Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures.
* Executes equipment qualifications, validation protocols, and process improvement studies.
* Schedules and performs periodic field review of validated computer systems
* Conducts investigations into qualification failures, develops and implements remediation plans
* Oversees vendors for qualification and metrology functions.
* Initiates, guides and reviews written procedures for calibration and preventive maintenance of stand-alone computerized systems
* Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques.
* Preferred BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
* Preferred 5 years of experience in FDA-regulated GMP lab environment
* VERY IMPORTANT - Must have experience using or working with stand-alone computerized lab systems