Specialist III, Validation

About the role

The Validation Specialist III is responsible for validating multiple types of GMP systems, sterilization processes, and cleaning processes using an integrated commissioning and qualification approach. Experience with qualification of DeltaV systems is required, while experience with qualification of Data Historian, Building Automation Systems, and Manufacturing Execution Systems is preferred.

Responsibilities

• Works independently to qualify multiple types of GMP systems (e.g., utilities, facilities, lab instruments, cell culture process equipment, and computer systems including DeltaV, Building Automation System, Data Historian), sterilization processes, and cleaning processes.
• Utilizes SOPs to develop validation protocols and summary reports.
• Executes protocols and collects samples in support of qualification/validation studies.
• Active member of integrated team where interaction with various groups is required to coordinate, plan, and execute work including new facilities or complicated changes.
• Ensures that current industry standards and guidelines are reviewed and implemented.
• May be a CQV lead for major projects (e.g., new equipment or systems) or validation subjects within the facility.
• Develops data analysis tools and acceptance criteria utilizing industry guidance and regulatory standards.
• Led major/complex deviation investigations utilizing root cause analysis and investigation tools.
• Proven ability to drive to root cause identification and implement corrective actions.
• Participates in audits as subject matter experts in area of responsibility.
• Leads the coordination and execution of validation activities with the appropriate system owners and other affected departments.
• Integrates validation maintenance activities into site schedules.
• Provides training to new/junior team members.
• Analyzes and reviews data as required to support specialist levels I and II.

Qualifications

• 5+ years of hands-on commissioning, qualification and/or validation experience OR equivalent required.
• 3+ years of pharmaceutical manufacturing related experience preferred.
• Previous experience with managing contract staff preferred.
• Previous experience with audit defense preferred.
• Bachelor’s degree is required in Engineering, technical or science related field.