Entity: CSL Seqirus

Job Category: Quality

Job Family: Validation

Job Type: Full Time

Location: Holly Springs, North Carolina, United States

Employer Reference: R-283231

Reporting to the Manager of Validation, the Validation Specialist III is responsible for validation lifecycle activities for equipment and computer systems using an integrated commissioning and qualification approach. Experience with qualification of DeltaV systems is required. 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. Ensure that current industry standards and reviewed and implemented. May be 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.
• Leads 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. Analysis and review of data as required to support specialist levels I and II.
• Other job duties that may be assigned from time to time.

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 defence preferred.
• Bachelor’s degree is required in Engineering, technical or science related field.