Validation Supervisor - Pharmaceutical

JOB TITLE
Validation Supervisor

 

OUR CLIENT
Global leader in the manufacture of  pharmaceuticals. 

 

JOB SUMMARY
Supervising a staff comprised of 2 to 5 Validation Engineers (Levels I and II) and Technicians to support not only current validation/revalidation programs but also production, Scientific Affairs, and contract manufacturing operations with validated processes/equipment.

 

RESPONSIBILITIES
* Supervise and coordinate activities of 2-5 Validation personnel. Provide technical support and guidance to other validation personnel or project team in protocol/report preparation, execution and data interpretation.
* Reviews validation protocols and uses data analysis skills in assuring accurate interpretation of data.
* Track projects to ensure completion within defined time lines.
* Writing, reviewing, or revising SOPs as related to validation policies or revalidation activities, as needed.
* Independently prepare written validation protocols including designing appropriate test experiments.
* Assists the validation manager in providing technical assistance and handling any questions or concerns from contract customers or agencies in reference to validation activities
* Follows Safety, Health, and Environmental policies and procedures.
* Other duties, as assigned, or as business needs require.

 

REQUIREMENTS / QUALIFICATIONS
* Bachelor?s degree in Biological/Life Sciences or Engineering and 4-6 years experience in pharmaceutical manufacturing or related field.
* Experience Required: Minimum of 3 years experience in validation.
* Experience Preferred: Minimum of 4 years experience in validation and at least two years supervisory experience/project management.
* Specialized or Technical Knowledge, Licenses, Certifications needed: In-depth knowledge of validation functions to support manufacturing, cGMPs, CFRs, pharmaceutical equipment and processes required.

 

COMPETENCIES
Demonstrated proficiency in a minimum of 3 of the following specific areas of validation:
* Terminal sterilization/depyrogenation
* Aseptic processes (filling, compounding)
* Pharmaceutical equipment/systems
* Facilities/utilities
* Computer systems (including PLC)
* Packaging/inspection equipment
* Process validation (fill volume, headspace, etc.)
* Cleaning validation

 

COMPUTER SKILLS
* Computer literate and good working knowledge of MS Word, MS Excel, and MS Project, a plus.
* Knowledge of use of instrumentation to conduct validation testing (e.g. Kaye Validator) required.

 

LOCATION
Irvine, CA

 

TERMS / RATES
$85k+
Direct hire only

 

BENEFITS
Client offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company.