Engineer-Process Validation

Job Description

• 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.

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.