Validation Engineer – Pharma & Med Device (IQ/OQ/PQ, CSV)

Stark Pharma Solutions Inc; West Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a Validation Engineer to support commissioning, qualification and validation activities across manufacturing equipment, processes, and computerized systems in a cGMP environment. This hands-on role collaborates with Engineering, Manufacturing, Quality and Automation teams.

Responsibilities include authoring IQ/OQ/PQ protocols, performing CSV activities, and ensuring regulatory readiness.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or a related technical discipline.
• 3-5 years of validation experience in cGMP pharmaceutical, biotech or medical device manufacturing.
• Hands-on experience authoring and executing IQ/OQ/PQ protocols.
• Working knowledge of 21 CFR Part 11 and/or 21 CFR Part 820.
• Familiarity with GAMP 5 and risk-based validation.
• Experience with deviations, change control and CAPA.
• Strong technical writing and documentation skills.
• Must be legally authorized to work in the United States.
• W2 employment only.

Responsibilities

• Author, review and execute IQ/OQ/PQ protocols for manufacturing, packaging and laboratory equipment.
• Execute CSV activities for GxP computerized systems from URS through validation summary report.
• Prepare validation plans, risk assessments and requirements traceability matrices.
• Perform field verification and system walkdowns, documenting and resolving discrepancies.
• Investigate validation deviations and support root cause analysis and CAPA closure.
• Assess change controls for validation impact and update affected documentation.
• Support audit and regulatory inspection readiness.

Skills

IQ/OQ/PQ execution

CSV for GxP systems

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Stark Pharma Solutions Inc is seeking a Validation Engineer to support commissioning, qualification and validation activities across manufacturing equipment, processes, and computerized systems in a cGMP environment. This hands-on role collaborates with Engineering, Manufacturing, Quality and Automation teams.

Responsibilities include authoring IQ/OQ/PQ protocols, performing CSV activities, and ensuring regulatory readiness.