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Software Validation Engineer 3 8/10/2016

Pacira Pharmaceuticals Inc San Diego, CA

Company
Pacira Pharmaceuticals Inc
Job Classification
Full Time
Company Ref #
a15A0000002ZQWQIA4
AJE Ref #
575842348
Location
San Diego, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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DESCRIPTION

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.

QUALIFICATIONS:

* 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.