Manager, Quality Engineering Method Transfer & Stability

Posted on May 4, 2021 by CSL Behring

Kankakee, IL 60901
Engineering
Immediate Start
Annual Salary
Full-Time


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 the second largest influenza vaccine company 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 Quality Engineering Methods Transfer & Validation Leader, the Manager, and Methods Transfer & Validation will be provide oversight for projects covering methods transfer & validation. The individual will partner with the process and product owners of Capex projects at the manufacturing site.



  • The incumbent will have demonstrated strong technical knowledge in methods transfer, validation, and cGMP compliance. They will support QA oversight of quality standards and systems aligned with the Engineering functions in the above areas. They will be experienced in associated regulatory inspections

  • This role will be responsible for activities in Methods Transfer, Method Validation Stability studies (incl. intermediates), E&L studies, analytical comparability, Process improvements, 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.

Provide Quality Assurance Oversight including issue and Risk Management for local capital investment projects in area of responsibility (Methods Transfer & Validation).

  • 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.

  • Support regulatory document submissions and pre-approval inspections for capital projects.




Provide Quality Assurance Oversight including issue and Risk Management, for methods transfers, and validation

  • Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all methods transfers and method validation to deliver these changes on time and to the required standards.

  • Carries out Quality decisions regarding methods transfer, method validation and comparability studies are aligned with the direction of the organization.

  • Participate in risks assessments and ensures up-to-date information

  • Ensure the development of a robust stability program based on historical data (statistics)

  • Ensure that required E&L studies are performed and in alignment with guidelines

  • Supports Process Engineering and Sites in improvements projects and provides QA guidance

  • Ensures quality is represented appropriately for regulatory document submissions and regulatory inspections for technical transfer and the corresponding activities




Provide Quality Assurance Oversight for Engineering Standards & Engineering Documentation and Knowledge Management in Methods Transfer & 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

  • Contribute to internal and authority pre- and post-approval inspections




Qualifications:
• 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

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Worker Type:
Employee

Worker Sub Type:
Regular

Reference: 1187779144

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