Engineer, Process and Cleaning Validation

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.

Minimum 6 years of experience in biopharmaceutical industry supporting manufacturing in a process validation, cleaning validation, process engineering, MST, process development, or other manufacturing support related capacity.

Experience with quality risk management tools and methodologies.

Technical writing and documentation skills.

Project management and communication abilities.

Must be able to travel up to 25%.

We are seeking an experienced Process and Cleaning Validation subject matter experts to provide Validation support for development of the process and cleaning validation programs, strategies to be applied to early processes entering these validation programs, and expertise in validation project management and technical document preparation as needed.

Design and implement approaches for validation studies, using knowledge and input from Process Development, Analytical Development, Manufacturing, MST/ENG, and Quality partners.

Develop and execute validation master plans and/or project plans, protocols, and reports for process and cleaning validation activities.

Conduct risk assessments and gap analyses of existing validation programs to identify areas for improvement.

Evaluate equipment design and manufacturing process procedures to establish scientifically sound acceptance criteria for PQ studies.