Validation Engineer

Job Title: Validation Engineer – Equipment Characterization

Location: IL

Employment Type: Contract (1 Year+)

Job Responsibilities

• Develop, execute, and generate equipment and process characterization protocols and technical reports.
• Perform equipment and process characterization studies for pharmaceutical assembly and packaging equipment.
• Challenge equipment functionality and performance against User Requirement Specifications (URS) to verify design intent and operational requirements.
• Conduct Design of Experiments (DOE), engineering runs, parameter mapping, sampling studies, and statistical analysis.
• Troubleshoot equipment and process issues, investigate unexpected results, and perform root cause analysis.
• Support commissioning, equipment qualification, startup activities, and equipment readiness assessments.
• Identify equipment deficiencies and recommend corrective actions based on study results and technical evaluations.
• Analyze characterization data, document findings, and prepare technical reports.
• Collaborate with Engineering, Validation, Quality, and Manufacturing teams to resolve technical issues.
• Ensure activities comply with applicable pharmaceutical manufacturing and GMP requirements.

Required Qualifications

• Experience in equipment validation, process characterization, equipment qualification, or commissioning within a regulated manufacturing environment.
• Hands-on experience developing and executing protocols and preparing technical documentation.
• Knowledge of equipment troubleshooting, root cause analysis, and technical problem-solving.
• Experience evaluating equipment performance against User Requirement Specifications (URS).
• Familiarity with Design of Experiments (DOE), engineering runs, parameter mapping, sampling studies, and statistical analysis.
• Strong analytical, documentation, and communication skills.
• Pharmaceutical or GMP manufacturing experience is preferred.
• Direct experience with assembly or packaging equipment is highly desirable.

Pay Scale

• Anticipated hourly pay range: $40–$45 per hour.

Work Schedule

• Shift: Third shift (overnight).

Employees hired into this position are eligible for the following benefits, subject to 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 is provided other than that required by applicable state and local laws.