What are the responsibilities and job description for the Manager, Validation position at CSL?
Summary
Reporting to the Site Head of Validation, the Manager provides managerial direction and technical leadership for the Bulk Manufacturing/Warehouse team of Validation Specialists. Manages CQV support of routine operations and projects in Bulk/Warehouse departments. This includes support for the design, start-up, commissioning and qualification of equipment and associated computer systems, facilities, and utilities. Additional responsibilities include ensuring compliance with Seqirus policies and procedures, managing and developing staff, and financial management and supervision of contractor resources for project support.
Accountabilities
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at 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
Equal Opportunity Employer
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.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
Reporting to the Site Head of Validation, the Manager provides managerial direction and technical leadership for the Bulk Manufacturing/Warehouse team of Validation Specialists. Manages CQV support of routine operations and projects in Bulk/Warehouse departments. This includes support for the design, start-up, commissioning and qualification of equipment and associated computer systems, facilities, and utilities. Additional responsibilities include ensuring compliance with Seqirus policies and procedures, managing and developing staff, and financial management and supervision of contractor resources for project support.
Accountabilities
- Responsible for commissioning and qualification for cGMP equipment and associated computer systems, facilities, and utilities (IOPQ). Validation responsibilities include cleaning, sterilization and decontamination, dirty, clean and sterile hold, and classified space environmental qualification. Facilitates management of validation maintenance assignments within Bulk/WH on time to meet department objectives. Develops and completes CQV deliverables to schedule and budget for projects within Bulk/WH. May include oversight of CQV contractor resources when applicable for projects or backfilling of FTE specialist resources.
- Provides strong leadership, direction and organizational planning skills for their team of Validation Specialists and also for contractor resources when required. Responsible to mentor and develop their staff technically and professionally. Cascades functional deliverables in alignment with the site and department objectives, providing clear vision of goals and tangible results.
- Acts as lead presenter during FDA inspections for areas of responsibility/expertise.
- Ensures creation and implementation of site procedures for a robust and compliant Commissioning, Qualification, and Validation Program. Maintains oversight to develop and maintain applicable Building and/or Subject Matter Validation Master Plans.
- Interacts with Quality Assurance to ensure site facilities, systems and processes remain in a validated state.
- Bachelor's degree in science or engineering
- 8 years of progressive experience in qualification & validation preferred (6 years minimum required) with thorough working knowledge of cGMPs and validation principles required.
- Demonstrated leadership of teams and/or projects
- Working knowledge of FDA expectations around qualification
- Proven regulatory authority interaction
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at 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
Equal Opportunity Employer
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.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus