Conduct qualification and validation studies for manufacturing processes, equipment, and utilities; provide technical assistance, as needed, for manufacturing and engineering troubleshooting; responsible for the coordination of supportive validation activities (such as laboratory testing, calibration, scale-up and engineering studies) and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations; evaluate qualification and validation projects to establish technically and scientifically sound protocols and test plans; execute protocols by carrying out the preapproved testing in the operations and laboratory areas; collect and analyze all data, write final report and obtain approvals; review technical documentation (batch records, SOPs, calibration records, preventive maintenance, work orders, protocols, reports) for continuity and accuracy; perform gap assessments and remediation as required on legacy qualification and validation packages; write SOPs and protocols to support departmental programs and projects; evaluate, maintain and operate validation instrumentation as required in order to support assigned projects (examples: Kaye Validator 2000, dew point monitor); and coordinate successful execution of projects by working effectively with cross-functional groups; and may be involved in investigation and root cause analysis for incidents reported on validated systems. Bachelor’s degree or equivalent in an Engineering related field. 2 years of experience in the job offered or in a validation and/or compliance engineering role.