Engineer, Validations

About the Role

Looking to join a passionate team dedicated to developing and manufacturing life‑saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Validation Engineer I supports commissioning, qualification, and validation activities for GMP equipment, utilities, facilities, and computerized systems, and assists in developing and executing validation protocols, technical reports, and related documentation to ensure compliance with company procedures, regulatory requirements, and industry standards.

Key Responsibilities

• Support qualification and validation activities for GMP equipment, utilities, and facilities.
• Review 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 for GMP equipment/systems and utilities, including pallet tanks, temperature control units, controlled temperature chambers (cold rooms, freezers, refrigerators, incubators), compressed gases, air‑handling/roof‑top units, WFI system, and 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, verify acceptability, and ensure compliance with the approved protocol.
• Address any discrepancies to protocols or acceptance criteria.
• Participate in 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.

Minimum Qualifications

• BA/BS in a science (e.g., Biology, Microbiology, Biochemistry, Chemistry), engineering (e.g., Electrical, Electronics, Computer Science) or other equivalent technology‑related field.
• 2–4 years of experience in validation or a related pharmaceutical/biotechnology industry.
• Experience supporting equipment qualification and utility validation activities (preferred).
• Familiarity with IQ/OQ/PQ execution and GMP documentation practices.
• Experience working within FDA‑regulated or other regulated manufacturing environments (preferred).
• Experience with temperature‑mapping systems (e.g., Ellab ValSuite, Lives, or similar).

Pay

The compensation range for this role is $92,800 – $116,000 annually, depending on experience and qualifications.

Benefits

• Base salary
• Performance‑based bonuses
• Health, dental, and vision insurance
• 401(k) matching
• Paid time off
• Career growth and development opportunities
• Supportive and inclusive work environment

Schedule

This is a full‑time onsite position. Standard hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. Overtime and weekend work may be required as needed.

Physical Demands & Work Environment

The role involves a mix of regular activities such as sitting, standing, and walking, with occasional tasks requiring lifting up to 25 lb. The work environment may expose employees to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. Reasonable accommodations are available to support individuals with different abilities. Good visual acuity—including close, distance, and color vision—is essential for daily duties.