Manager, Quality Engineering Commissioning & Qualification
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Reporting into the Leader, Quality Engineering Process Life Cycle the Sr. Analyst, Quality Engineering Commissioning & Qualification will perform Quality oversight activities for technology transfers, validation and life cycle management. The individual will be accountable for process and product quality of commercial products and of Capex projects of a manufacturing site.
- The incumbent will have demonstrated strong technical knowledge in the one or more areas of commissioning, qualification and cGMP compliance. They will support QA oversight of quality standards and systems aligned with the Engineering function in the above areas. They will be experienced in associated regulatory inspections
- This role will be responsible for activities in one or more of the following areas: all transfers to commercial, internal & external: Commissioning & Qualification, , Commissioning, Qualification, System Verification/commissioning, URS, Risk analysis, IQ/OQ/PQ, Requalification , SOPs review & approval, Deviation (oversight), Changes, Inspections
- The incumbent will foster industry best practices and implement into site processes
The incumbent will work with the teams within of Global Engineering
The incumbent will work closely with his or her peers in Quality Engineering from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects the appearance of the documentation in the stated areas is standardized.
The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.
Conduct Quality Assurance Oversight activities including issue and Risk Management for local capital investment projects in area of responsibility (Commissioning & Qualification).
- Collaborate with internal partners for the execution of all capital projects – EU, AUS and US and others – to deliver projects on time and to the required standards and regulatory requirements.
- Delivers a consistent quality approach to facility and process design and development for capital projects
- Provide QA oversight on process within capital project.
Conduct Quality Assurance Oversight activities including issue and Risk Management, for Commissioning & Qualification
- Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of commissioning and qualification activities to deliver these changes on time and to the required standards.
- Supports Quality decisions regarding C&O activities are aligned with the direction of the organization.
- Supports risks assessments and ensures up-to-date information
- Supports definition of requalification cycles and requirements for maintenance activities
- Supports Process Engineering and Sites in improvements projects and provides QA guidance
Conduct Quality Assurance Oversight activities for Engineering Standards & Engineering Documentation and Knowledge Management in Validation
- Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
- Provides input to engineering on the content of an appropriate Documentation and Knowledge Management system for the Engineering function.
- Responsible for the approval of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the entire capital project.
- Delivers against global standards for technology transfer and , validation
- Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports.
- Facilitate global and local change controls
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements