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.
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
