Validation Engineer

Shoolin Inc; Illinois; Sur place; USD 55 000 - 62 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) retirement plan

PTO as per state laws

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Equipment validation

Process characterization

Root cause analysis

DOE

Statistical analysis

Documentation

Description du poste

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.