Validation Engineer III Job in San Diego 92121, California US
position description
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Validation Engineer, Level III to work for a leading San Diego biotechnology company.
Validation Engineer, Level III
Summary:
The primary purpose of this position is to support the overall Validation Program by conducting qualifications, specialty studies and preparation validation documentation. This includes the generation, development, modifying and routing of the Validation Protocols, Final Reports, Standard Operating Procedures, Equipment and Software Change Controls.
Essential Duties Responsibilities:
- Write Validation and Equipment SOPs, Protocols, Final Reports, and Equipment/Software Change Controls.
- Perform validation and revalidation testing including data collection and analysis.
- Perform sampling for QC analysis in support of cleaning and aseptic processing validations.
- Work with other departments to complete validation testing.
- Perform other duties as directed by supervisor.
Education and Experience:
- Minimum of 5 year of relevant Pharmaceutical Validation experience.
- BS degree in scientific field or equivalent experience.
Knowledge, Skills, and Abilities:
- Understanding and practice of cGMPs.
- Software proficiency - basic word processing and spread sheet applications.
- Ability to write validation SOPs, Protocols and Final Reports.
- 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 as well as team oriented.
- Effective oral, written, and interpersonal communication skills.
- Experience with IQ, OQ, PQ, APV and Cleaning studies.
- Experience with validation of WFI systems, HVAC systems, SIP and CIP, Dry Heat Tunnels and Ovens, Vial, Autoclaves, Glassware Washers, Cleaning Validation, HEPA certification, Aseptic Filling Operation Validation and other utilities and pharmaceutical equipment validation.
- Provide subject matter expertise during inspections and regulatory audits
- Experience with Data Acquisition set up, programming and thermocouple calibration.
- Incumbent may need DEA clearance in order to perform some validation studies.
Contact jjyarlott@biophaseinc.com if interested, and visit www.biophaseinc.com to view all our current openings!