Manufacturing Process Validation Engineer - Medical

Hi,

Hope you are doing good,

My name is Gangadhar Reddy, and I'm a Delivery Lead at Intellectt Inc. Please find the below requirement and if interested kinldy share with me your updared resume to

Job Title: Process Validation Engineer

Location: New Albany, OH

Duration: Long Term

Job Description:

Our client is seeking a Characterization Consultant to support equipment and process characterization activities within a pharmaceutical manufacturing environment, with a focus on assembly and packaging equipment.

Day-to-day responsibilities will include protocol development, execution, and generation; troubleshooting; design documentation; root cause analysis; and technical report generation.

Consultants will challenge equipment functionality and performance against User Requirement Specifications (URSs) to verify that systems meet design intent and operational requirements.

Additional responsibilities may include commissioning support, identifying equipment deficiencies, investigating unexpected results, performing root cause investigations, and collaborating with Engineering, Validation, Quality, and Manufacturing teams to resolve technical issues and ensure equipment readiness.

The ideal candidate will have experience conducting equipment and process characterization studies, including Design of Experiments (DOE), process characterization, engineering runs, parameter mapping, sampling studies, and statistical analysis.

Candidates should be comfortable evaluating equipment performance, analysing data, documenting results, troubleshooting issues, and developing recommendations based on study outcomes.

Experience with commissioning, equipment qualification, and technical documentation is highly desirable.

Direct experience with assembly or packaging equipment is a strong plus, particularly for candidates who have challenged equipment against URSs, performed root cause analysis on equipment or process failures, and supported commissioning or startup activities in a regulated manufacturing environment.

Prior pharmaceutical or GMP experience is preferred.

Skills: characterization studies, including DOE, engineering runs, parameter mapping, and sampling studies, to establish process windows and optimal operating parameters.