Process Development Engineer —Equipment & Process Characterization

Equipment and Process Characterization | Protocol Development and Execution | Root Cause Analysis | Troubleshooting | DOE | Statistical Analysis | Technical Documentation. The role focuses on evaluating assembly and packaging equipment, troubleshooting technical issues, and documenting equipment performance and readiness.

Role: Process Development Engineer -Equipment & Process Characterization
Company: Intellectt Inc
Location: New Albany, Ohio
Duration: 2 years+
Pay range: ($40/hr - $45/hr on W2)Position Overview

We are seeking a Process Development Engineer / Characterization Consultant to support equipment and process characterization within a pharmaceutical manufacturing environment. The role focuses on evaluating assembly and packaging equipment, troubleshooting technical issues, and documenting equipment performance and readiness.

Key Responsibilities

• Develop, execute, and document equipment and process characterization protocols.
• Challenge equipment functionality and performance against User Requirement Specifications (URSs) to verify design intent and operational requirements.
• Conduct Design of Experiments (DOE), engineering runs, parameter mapping, sampling studies, and statistical analysis.
• Evaluate study results and recommend improvements to equipment performance and process reliability.
• Troubleshoot equipment and process issues, identify deficiencies, and investigate unexpected results.
• Perform root cause investigations and support resolution of technical issues.
• Prepare design documentation, technical reports, study summaries, and recommendations.
• Support commissioning, equipment qualification, and startup activities.
• Collaborate with Engineering, Validation, Quality, and Manufacturing teams to ensure equipment readiness.

Required Qualifications

• Experience conducting equipment and process characterization studies.
• Experience developing and executing protocols and preparing technical documentation.
• Knowledge of DOE, parameter mapping, sampling studies, and statistical data analysis.
• Strong equipment and process troubleshooting skills.
• Experience performing root cause analysis and investigating unexpected results.
• Ability to evaluate equipment performance against URSs and operational requirements.
• Strong technical writing and cross-functional collaboration skills.

Preferred Qualifications

• Direct experience with assembly and/or packaging equipment.
• Experience supporting commissioning, equipment qualification, or manufacturing startup activities.
• Pharmaceutical manufacturing or GMP-regulated industry experience.

Core Skills

Equipment and Process Characterization | Protocol Development and Execution | Root Cause Analysis | Troubleshooting | DOE | Statistical Analysis | Technical Documentation

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com

+1 (732) 737 8381