The Validation Specialist will conduct process validation studies for manufacturing and packaging processes
- Provides 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.
- Generate, review, approve and maintain Validation Master Plan and Summary Reports and other Process validation lifecycle documents.
- Evaluate Process validation projects to establish technically and scientifically sound protocols and test plans.
- Execute protocols by carrying out the pre-approved testing in the operations and laboratory areas.
- Collect and analyze all data, write final reports 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 validation packages.
- Write SOPs and protocols to support departmental programs and projects.
- Coordinate successful execution of projects by working effectively with cross-functional groups.
- May interface with the FDA and customers during site audits to respond to validation-related questions
- May be involved in investigation and root cause analysis for incidents reported on validated systems
- Other duties as assigned
- At least 5 years of demonstrated direct (hands-on) validation experience in at least three of the following areas: Process Validation, Cleaning validation, tablet manufacturing/finishing, sterile/aseptic operations, utilities qualification, active ingredient synthesis, automated controller/computer qualification.
- Ability to work harmoniously and effectively with others in a fast-paced environment.
- Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
- Flexibility to work off-hours and weekends as required to support manufacturing plant projects
- Ability to effectively manage multiple projects simultaneously (3-6 typical)
- May be required to wear personal protective equipment
- May be required to move about the facility
- May be required to remain sedentary for periods of time
- Bachelor’s degree in Engineering, in a scientific discipline, or equivalent experience