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Job Description

The successful Validation Specialist will be responsible for performing HVLD (High Voltage Leak Detection) validation to inspect sealed container types for container closure integrity of pharmaceutical products, as well as generating method and validation documentation.

Essential job functions:

• Writing validation protocols, coordinating and/or performing validation and writing validation reports to support validation of HVLD, ensuring that all test methods meet the USP and regulatory requirements

• Execution of validation protocols in coordination with other support groups such as GMS, Process validation, and Microbiology department.

• Write methods for HVLD use.

• Prepare documentation for regulatory filing.

Qualifications

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Microbiology, Engineering, etc)

• Experience in pharmaceutical industry with microbiological testing validation

• Experience with GMP laboratory operations and FDA regulations

• Possesses an understanding and experience of validation principles with good knowledge of Industry Standards and current validation and method development requirements.

• A strong sense of initiative is required for this position.

Qualifications

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Microbiology, Engineering, etc)

• Experience in pharmaceutical industry with microbiological testing validation

• Experience with GMP laboratory operations and FDA regulations

•
Possesses an understanding and experience of validation principles with
good knowledge of Industry Standards and current validation and method
development requirements.

• A strong sense of initiative is required for this position.

All your information will be kept confidential according to EEO guidelines.