Onsite Validation Engineer I - GMP Equipment & CQV

Avid Bioservices, Inc.; Irvine (CA); On-site; USD 93,000 - 116,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in Irvine, CA is seeking a Validation Engineer I to support commissioning, qualification, and validation of GMP equipment, utilities, facilities, and computerized systems.

You will develop and execute CQV protocols and final reports, review URS/Requirements, coordinate with QA, Manufacturing, Facilities and Engineering, and ensure compliance with cGMP, FDA, EU GMP and GAMP 5 guidelines.

Qualifications

• BS or higher in science or engineering with relevant experience.
• Experience in validation in pharmaceutical/biotech industries.
• Familiarity with IQ/OQ/PQ and GMP documentation practices.

Responsibilities

• Support qualification and validation activities for GMP equipment, utilities, and facilities.
• Review URS and FS documents for equipment and processes.
• Generate and execute CQV protocols and final reports compliant with GMP and regulatory requirements.
• Coordinate validation protocol execution with cross-functional teams.
• Ensure validation documentation complies with cGMP, FDA, EU GMP, and GAMP 5.

Skills

Validation

IQ/OQ/PQ

GMP documentation

Temperature mapping

Analytical instruments

Education

BS in science or engineering

Tools

Ellab ValSuite

Lives

P&IDs

Job description

Avid Bioservices in Irvine, CA is seeking a Validation Engineer I to support commissioning, qualification, and validation of GMP equipment, utilities, facilities, and computerized systems.

You will develop and execute CQV protocols and final reports, review URS/Requirements, coordinate with QA, Manufacturing, Facilities and Engineering, and ensure compliance with cGMP, FDA, EU GMP and GAMP 5 guidelines.