Company: Akorn, Inc
Posted on: November 22, 2021
SUMMARY: 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. Assists the Manager in the
scheduling and coordination of staff to meet aggressive project
timelines. Provide management oversight for the Validation efforts
at Akorn, Decatur. Work towards improving validation practices and
procedures; ensure site compliance with current FDA regulatory
requirements. This individual must be detail-oriented and
compliance-minded with an understanding of cGMP, and other FDA
Guidance Documents. This individual must have the expertise to
interface with all levels of management, staff and internal
departments, including outside contractors and vendors as
applicable. They must be able to multitask within a high-stress
environment to maintain critical timelines. ESSENTIAL
- Track and report on progress to project deliverables,
- Review, analyze and interpret system performance data for
completed qualification and prepare final package to summarize
- Demonstrate solid communication and documentation skills.
- 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
- 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
investigations.Lead the effort to gain approval of validation
protocols and summary reports.
- 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
- Coordinate training of new employees of the Validation
- Additional responsibilities as required.
- 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, Engineering , Decatur, Illinois
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