Engineer, IT Systems Compliance

Avid Bioservices • Tustin, CA

36d • $82,000 - $104,400

About The Position

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. Your Role: The Engineer, IT Systems Compliance is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.

Requirements

• BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
• Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.

Responsibilities

• Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
• Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements.
• 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 deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
• Provide input and assist on the development of validation policies and procedures.
• Effectively interact and provide validation guidance to other departments.
• Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
• Provide input and assist in change control assessment and Part 11 assessment for validated systems.
• Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflects validated conditions.
• Assist department manager on other types of projects/managerial responsibilities as needed

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees