Software Validation Engineer 3
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POST DATE 8/10/2016
END DATE 1/25/2017
Pacira Pharmaceuticals Inc
San Diego, CA
The primary purpose of this position is to support the overall Validation Program by conducting qualifications and preparing and/or executing validation documents. This includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls.
RESPONSIBILITIES (Including but not limited to):
* Write, review and or approve Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on complex software and computerized control systems.
* Perform validation and revalidation testing including data collection, analysis, and deviation resolution.
* Work with other departments to complete validation testing.
* Mentor personnel with respect to software and computer validation.
* Ensures self maintains a high degree of training compliance including completion of training on time .
* Perform other duties as directed by supervisor.
* Minimum of 5 years of relevant pharmaceutical validation experience
* BS degree in software engineering or a related discipline or additional years of equivalent experience
* Knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance).
* Experience in the validation of PLC, SCADA and HMI.
* Advanced understanding and practice of cGMPs.
* Advanced software proficiency - word processing and spread sheet applications.
* Understanding of validation principals and techniques for software and computerized systems as applied in the pharmaceutical industry.
* Ability to write validation Protocols, Deviations, Final Reports, SOPs, and Change Controls for complex automation, or software and/or computerized systems.
* Ability to work in an organized and detail-oriented fashion.
* Ability to manage multiple responsibilities with a high degree of self-motivation.
* Ability to work both independently and in a team environment.
* Excellent oral, written, and interpersonal communication skills.
* Experience with IQ, IOQ, OQ, PQ and Validation Summary Reports.
* Provide subject matter expertise during inspections and regulatory audits..