GMP Validation Engineer: CQV & Process Expert

Stark Pharma Solutions Inc; Illinois; On-site; USD 90,000 - 140,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Manufacturing Validation Engineer in Lake County, IL to support GMP-compliant manufacturing operations.

The role focuses on executing validation activities, IQ/OQ/PQ, CQV, and equipment qualification within regulated pharma/medical device environments. You will develop and review validation protocols, reports, and support documentation, while collaborating with Quality Assurance, Engineering, and Validation teams to ensure audit-ready records and

Qualifications

• Bachelor's or master's degree in Engineering or related technical field.
• Hands-on experience in IQ/OQ/PQ, CQV, and validation within pharma/medical device industries.
• Familiarity with GMP, FDA, ISO standards, and validation documentation.
• Experience with deviation investigations, CAPA, change control, and risk assessment processes.

Responsibilities

• Execute validation activities for equipment, utilities, and processes.
• Perform IQ, OQ, and PQ for equipment qualifications.
• Develop and review validation protocols and reports.
• Support process validation to ensure consistent product quality.
• Ensure GMP, FDA, ISO compliance and quality systems.
• Collaborate with cross-functional teams to support readiness.
• Investigate deviations and participate in CAPA and root-cause analysis.
• Maintain audit-ready validation lifecycle documents.
• Assist CQV activities for new equipment and systems.
• Contribute to continuous improvement of manufacturing efficiency.

Skills

Manufacturing Validation

CQV

Equipment Qualification

Process Validation

IQ/OQ/PQ

GMP/FDA/ISO

Validation Documentation

CAPA

Change Control

Risk Assessment

Regulatory Audits

CSV

Cleaning Validation

Utility Qualification

Cross-functional Collaboration

Education

Bachelor's or Master’s in Engineering

Job description

Stark Pharma Solutions Inc. is seeking a Manufacturing Validation Engineer in Lake County, IL to support GMP-compliant manufacturing operations.

The role focuses on executing validation activities, IQ/OQ/PQ, CQV, and equipment qualification within regulated pharma/medical device environments. You will develop and review validation protocols, reports, and support documentation, while collaborating with Quality Assurance, Engineering, and Validation teams to ensure audit-ready records and