Senior validation engineer vs equipment validation specialist

Differences between senior validation engineer and equipment validation specialist duties and responsibilities

Senior validation engineer example responsibilities.

• Manage changes, deviations, investigations, and CAPAs via TrackWise.
• Maintain and manage positive working relationships while assisting in all stages of CAPA management and resolution.
• Manage all site validation activities including equipment qualification, management of outside validation consultants, change control and QA calibration approval.
• Major focus are to review, participate in process validation, FMEA, remediation, IQ/OQ/PQ.
• Develop validation protocols (IQ/OQ/PQ), write test scripts and lead process validation activities for various manufacturing processes.
• Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validate state of all GMP equipment and systems.
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Equipment validation specialist example responsibilities.

• Manage all cleaning validation schedule and coordinate activities with QA and/or external laboratories and operations.
• Maintain accurate document control for GMP projects.
• Coordinate validation relate activities in regards to equipment and processes being deploy in GMP environments.
• Examine and document pharmaceutical manufacturing lines for adherence to FDA guidelines; develop operating manuals for industrial manufacturing lines and machinery.
• Complete numerous work files of data electronically, update and correct missing, inaccurate and incomplete data information via CDMD-OA.
• Maintain and organize data associate with the execution of qualification/validation relate activities.
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