CSV Engineer opportunity with our growing biotechnology client in Southern CA! You will be part of a motivated team and work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform CSV activities under the Quality Engineering scope of work.
Daily Responsibilities:
Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP, etc.)
Participate in site projects and manage all activities in regards to validation and qualification of computer systems and applications
Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors
Who You Are:
Bachelors’ degree in computer science, engineering or science discipline required
Minimum of 5 years of hands-on experience in computer system validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards
732-661-0400
info@astrixinc.com