Avid Bioservices · 15 hours ago
Engineer, IT Systems Compliance
Tustin, CA
Full-time
Onsite
Mid Level
$82K/yr - $104K/yr
3+ years expAvid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Engineer, IT Systems Compliance is responsible for providing technical validation support for manufacturing equipment and systems within a cGMP Manufacturing Facility, ensuring compliance with regulatory requirements and overseeing validation activities across departments.
BiotechnologyHealth CareMedical
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
Qualification
Required
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
Benefits
Health, dental, and vision insurance
401(k) matching
Paid time off
Company
Avid Bioservices
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.
201-500 employees
H1B Sponsorship
Avid Bioservices has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$285M2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M
Leadership Team
Kenneth Bilenberg
President & Chief Executive Officer
Richard McAvoy
Chief Business Officer
Recent News
2026-01-17
2026-01-16
2025-11-13
Company data provided by crunchbase