Engineer, Validations

Avid Bioservices•Irvine, CA

14d•Onsite

About The Position

The Validation Engineer I is responsible for supporting commissioning, qualification, and validation activities for GMP equipment, utilities, facilities, and computerized systems. This role assists in the development and execution of validation protocols, technical reports, and related documentation to ensure compliance with company procedures, regulatory requirements, and industry standards. The Validation Engineer will work cross-functionally with Quality Assurance, Manufacturing, Facilities and Engineering, Supply Chain and external vendors to support validation initiatives and maintain the validated state of GMP systems.

Requirements

BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
2-4 years of experience in validation or related pharmaceutical/biotechnology industry experience.
Familiarity with IQ/OQ/PQ execution and GMP documentation practices.
Experience with using temperature mapping systems (e.g., Ellab ValSuite, Lives, or similar systems).

Nice To Haves

Experience supporting equipment qualification and utility validation activities is preferred.
Experience working within FDA-regulated or other regulated manufacturing environments is preferred.

Responsibilities

Support qualification and validation activities for GMP equipment, utilities, and facilities.
Review and User Requirement Specification (URS ) and /or Requirement Specification documents for equipment /systems and processes.
Generate and execute CQV (Commissioning, Qualification, and Validation) protocols and final reports that comply with corporate and regulatory requirements for GMP equipment /system and utilities, including: Palletanks Temperature Control Units Controlled Temperature Chambers (Cold Rooms, Freezer, Refrigerators, Incubators) Compressed Gases Air Handing/Roof Top Units WFI System Analytical Instruments
Review equipment documentation, including P&IDs, user manuals, calibration records, and engineering drawings.
Perform gap analysis of vendor provided protocols.
Perform temperature mapping requalification activities of GMP equipment (autoclave, depyrogenation oven, and controlled temperature chambers ).
Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
Ensure any discrepancies to protocols and /or to acceptance criteria are adequately addressed.
Participate and support SAT activities.
Ensure validation documentation complies with cGMP requirements, FDA regulations, EU GMP guidelines, GAMP 5 principles, and company procedures.
Maintain accurate and organized validation records in electronic and paper-based systems.