Qualifications

Minimum of 1 year 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
Proven track record in validation and qualification of complex computer systems
Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards
Experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP, Specifications, Risk assessments)
Excellent written and oral communication skills


Responsibilities

The CSV Engineer fulfills a critical role in GMP operations, supporting computer system validation activities for instrument validation
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.)
Work directly with local and central QA departments
Participate in site projects and manage all activities in regards to validation and qualification of computer systems and applications


Pay rate: ***- ***