The Process Validation Engineer will ensure consistent implementation of corporate and regulatory compliance of validation activities within a pharmaceutical manufacturing facility.
Primary functions of the role include:
Oversees trial runs of a production or production- related process to substantiate the validity of the equipment/process and completion of all associated documentation.
Works with project engineers and other support groups to have an in-depth understanding of new and existing equipment capabilities.
Tests critical and key process parameters to assure reliability, quality and proper documentation to support the associated process and results.
Develops a working knowledge within assigned area of responsibility of equipment function, design, and utilization.
Presents updates, reports and presentations as necessary to the department, plant staff and regulatory agencies.
Provides a key role in assuring the integrity of the manufacturing process.
Qualifications
Requirements:
BS/BA degree required in engineering or an engineering related field
Minimum of three years of experience, preferably in the pharmaceutical industry.
Proven ability to understand equipment design and functions to assure appropriate utilization and validation of the process.
Excellent multi-tasking skills and the ability to document details of the work performed are required.