Process Validation Engineer

We are looking for a Validation Engineer to join the team of a large nationwide medical device manufacturing client. This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies, work on validations including CAPAs and deviations.

Must Haves:

Bachelor’s degree in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, Biochemistry, or related field with 3 or more years relevant experience

Experience authoring and completing validation studies.

Understanding of cGMP requirements for validation documentation.

Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices

Experience authoring and building process validation studies for commercial GMP manufacturing processes

Experience troubleshooting/problem-solving and risk assessment/mitigation

Working knowledge of the science and technology for the major unit operations associated with manufacturing operations

Key Responsibilities:

Provide technical input to validation activities

Represent process validation during equipment installations

Support process validation Quality Systems

Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices

Participate in regulatory agency inspections for Process Validation

Serve as one of the main points of contact in communication to customers whose equipment and processes are being validated

Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities

Pay Rate of $40 an hour, depending on experience and education