Validation Engineer

Company: Akorn, Inc
Location: Decatur
Posted on: November 22, 2021

Job Description:

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 FUNCTIONS:

• Track and report on progress to project deliverables, schedules.
• Review, analyze and interpret system performance data for completed qualification and prepare final package to summarize data.
• 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 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 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 assessment.
• Coordinate training of new employees of the Validation Department.
• 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 10%.

Keywords: Akorn, Inc, Decatur , Validation Engineer, Engineering , Decatur, Illinois