- Job Level:
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
Bachelor’s degree in Engineering, in a scientific discipline, or equivalent experience
Experience & Skills Required
- 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