Process Validation

Position Summary

The Process Validation & Technical Standards Individual Contributor will be responsible for developing Validation and Technical Standards and Guidelines for Process validation and Technical transfer programs in the internal and external manufacturing network. This individual will be a part of the Global Technical Operations team and will report to the Director of Validation and Technical Standards.

Primary responsibilities include developing and maintaining Process Validation, continued process verification and other technical standards. This will ensure that technical guidelines are fit for purpose across multiple modalities and are updated as new modalities are introduced to the pipeline. The role will also support the development of a Knowledge Management framework for the Global Technical Operations department

The role will also support internal and external sites as they build and execute Process validation and tech transfer strategy to support the product pipeline The role will work across multiple functions and collaborate closely with Global Product Development, Site Technical Services, Site Validation teams, Quality and Regulatory functions to shape standards and guidelines that are compliant with current regulatory requirements and standards.

Principal Responsibilities

Develop and support the implementation of scientifically sound, fit for purpose standards and procedures for process validation and other technical procedures based on current regulations, industry standards and industry practices.

Deliver associated training to colleagues.

Support the implementation of innovative and efficient approaches to validation and technical transfer by internal and external sites incorporating science and risk-based approach.

Support the development and implementation of process validation plans and other validation documentation in collaboration with the validation and technical SME network.

Build strong cross functional working relationships with stakeholders (Quality, Development, Technical Services and CMOs) to ensure high quality deliverables meeting cGMP and validation requirements.

Requirements

Qualifications

A minimum of 6-8 years experience in the biopharmaceutical or pharmaceutical industry (Process Validation, Technical Services or Quality).

A minimum of 6 years direct experience in cGMP Process validation / technical transfer activities.

Extensive knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.

Excellent technical writing skills

Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.

Demonstrated active participation in industry and regulatory forums shaping validation practices and strategy.

Strong track record of working in a global and matrix environment and working cross functionally

Education

Minimum Bachelors degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.