Validation Engineer I
Company: Akorn, Inc
Posted on: January 16, 2022
Maintains and coordinates the Validation Master Plan.
Assists in the development, review, execution and closure of
validation protocols (IQ, OQ, PQ, VQ) by collection of raw data
used as supporting documentation.
Work towards improving validation practices and procedures; ensure
site compliance with current FDA regulatory requirements.
Track and report on progress to project deliverables,
Review, analyze and interpret system performance data for completed
qualification and prepare final package to summarize data.
Develop Installation, Operational Qualification, and performance
protocols for commissioning and validation.
Ensure that all work carried out is in compliance with the required
standards conforming to company, cGxP, SOPs, regulatory regulations
and guidelines, safety and environmental guidelines and assure that
acceptance criterion related to the protocols are met.
Develop technical scope of work documents and estimate time and
resources needed for projects.
Coordinate resources required to complete validation studies and
tests in a timely manner.
Analyze test data and report issues/discrepancies. Lead and
document investigations of failed validation test results through
Root Cause Analysis.
Write summary reports to summarize test results and
Lead the effort to gain approval of validation protocols and
Conducting System Compliance Risk Assessment.
Assist cross-departmental teams in authoring validation related
documentation, standard operating procedures, reports, system
quality reviews, identifying deficiencies, preparing CAPA's, test
scripts and change controls.
Coordinate cleaning validation activities. Prepare and execute
protocols and reports for cleaning development and validation.
Write technical cleaning evaluations as requested, including
calculations and deviations with root cause and impact
The job may require travel to vendor sites and/or R&D
facilities to complete required work. Expected travel of less than
Keywords: Akorn, Inc, Decatur , Validation Engineer I, Engineering , Decatur, Illinois
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