System validation engineer vs equipment validation specialist

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

System validation engineer example responsibilities.

• Lead the development effort of porting a modem software test suite to a different OS.
• Manage overall validation programs for the GMP products at the manufacturing facility and the contract manufacturing company.
• Create perl scripts and edit python scripts that enhance throughput and performance of debug and execution tools.
• Initiate investigation and identification of root cause for defects return from the field under FDA and GMP guidelines.
• Participate in the creation of program specific DFMEA.
• Develop and execute IQ/OQ/PQ's to support validation within a control environment.
Show more

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.
Show more