Process Validation Engineer 4
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Validation Engineer 4.
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.
- Write, review and or approve Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on complex process equipment, cleaning, aseptic processing, and utilities qualifications.
- Perform validation and revalidation testing including data collection, analysis, and deviation resolution.
- Perform sampling for QC analysis in support of cleaning and aseptic processing validations.
- Work with other departments to complete validation testing.
- Mentor personnel with respect to process equipment, cleaning, aseptic processing, and utilities validation.
- Ensures self maintains a high degree of training compliance including completion of training ‘on time’.
- Perform other duties as directed by supervisor.
The qualified candidate will possess the following:
- Minimum of 8 years of relevant pharmaceutical validation experience
- BS degree in scientific field or a related discipline or additional years of equivalent experience
- Advanced understanding and practice of cGMPs.
- Advanced software proficiency - word processing and spread sheet applications.
- Understanding of validation principals and techniques as applied in the pharmaceutical industry.
- Ability to write validation Protocols, Deviations, Final Reports, SOPs, and Change Controls for complex process equipment, cleaning, aseptic processing, and utilities 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, OQ, PQ, VMP and Validation Summary Reports.
- Provide subject matter expertise during inspections and regulatory audits.
Equal Opportunity Employer/Veterans/Disabled