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Quality Engineer - Automation Validation


Education and
Experience:
Bachelor's Degree in Engineering, Life Sciences or related discipline, with a minimum of 3 years of relevant experience performing validation activities within an aseptic pharmaceutical environment; or equivalent combination of education and experience

Understanding and feedback of Input / Output control sequence

Understanding and experience with "White Box" and "Black Box" testing

Understanding of PLC logic, control loops and sequencing. Basic understanding of sequel servers and databases. Confident in configuring Excel spreadsheet, spreadsheet functions and automated calculations.

Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.

General Purpose of Job:
Individual will generate protocols, execute protocols and generate final reports to support the qualification / validation of PLC, SCADA, PC and other controls based systems. The individual will be expected to oversee the overall qualification program with such control systems including support of review and modification of control systems / programs. The individual will not be required to program systems but must be able to read logic.

Essential Duties and Responsibilities:
Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation based systems.
Review program logic for equipment automation
Provide support for engineering and design of automated systems
Generate, review, and route qualification protocols, project plans, white papers and risk assessments
Execute protocols and assess supporting documentation and engineering turnover packages
Generate white papers regarding qualification impact and Part 11 impact, documentation matrix, document traceability and final reports
Assess Change Controls associated with changes to control systems
Able to independently perform testing for control systems, spreadsheet validation, and other automation based systems.
Able to perform complex assessments for computer systems against current industry compliance requirements.

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