Equipment Characterization Validation Engineer (Contract, Night Shift)

Shoolin Inc; Illinois; On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

PTO as per state laws

Job summary

Shoolin Inc. seeks a Validation Engineer – Equipment Characterization for a contract role in Illinois (IL).

You will develop and execute characterization protocols for pharmaceutical assembly and packaging equipment, challenging designs against URS and performing DOE and statistical analyses. This role requires hands-on validation experience in a regulated manufacturing environment and strong documentation skills.

Qualifications

• Experience validating equipment in regulated environments.
• Proven protocol development and technical documentation experience.
• DOE, sampling, and statistical analysis experience.
• Strong communication and documentation skills.
• Pharma or GMP manufacturing background preferred.

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 against URS to verify design intent and requirements.
• Conduct DOE, engineering runs, parameter mapping, sampling studies, and statistical analysis.
• Troubleshoot equipment issues, investigate results, and perform root cause analysis.
• Support commissioning, equipment qualification, startup activities, and readiness assessments.
• Identify equipment deficiencies and recommend corrective actions based on study results.
• 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.

Skills

Equipment validation

Process characterization

Root cause analysis

DOE

Statistical analysis

Documentation

Job description

Shoolin Inc. seeks a Validation Engineer – Equipment Characterization for a contract role in Illinois (IL).

You will develop and execute characterization protocols for pharmaceutical assembly and packaging equipment, challenging designs against URS and performing DOE and statistical analyses. This role requires hands-on validation experience in a regulated manufacturing environment and strong documentation skills.