Pharma Validation Specialist: IQ/OQ/PQ, GMP, CSV Expert

Akaasa Technologies; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Akaasa Technologies is seeking a hands-on pharmaceutical validation professional to support equipment, utilities and process validation within GMP systems. You will execute IQ/OQ/PQ protocols, manage deviations, and drive CAPAs while maintaining data integrity across validated systems.

The ideal candidate has 3+ years in pharma validation, strong regulatory knowledge (FDA/EMA/ICH/GAMP5), and collaborates with QA, QC, engineering, and manufacturing teams to ensure compliant, reliable operations.

Qualifications

• Bachelor's degree in life sciences, engineering, or related field.
• 3+ years validation experience in a pharmaceutical/GMP environment.
• Experience developing/reviewing/executing IQ/OQ/PQ protocols.
• Equipment, utilities, and process validation experience.
• Strong knowledge of FDA, EMA, ICH, GAMP5.
• Risk-based validation and validation lifecycle management experience.
• Data integrity knowledge and deviation investigations & CAPA experience.
• Validation documentation experience and cross-functional QA/QC/Engineering involvement.

Responsibilities

• Lead validation activities for equipment, utilities, and processes in GMP environments.
• Develop, review, and execute IQ/OQ/PQ protocols and associated documentation.
• Maintain validated GMP systems and ensure data integrity across systems.
• Investigate deviations, implement CAPAs, and drive corrective actions.
• Collaborate with QA, QC, Engineering & Manufacturing to ensure regulatory compliance.

Skills

Validation experience in Pharma/GMP

IQ/OQ/PQ execution

Data Integrity knowledge

Deviation Investigations

CAPA experience

Validation Lifecycle Management

Cross-functional collaboration

Risk-Based Validation

Documentation experience

GMP systems maintenance

FDA/EMA/ICH/GAMP5 knowledge

Education

Bachelor's Degree in Life Sciences, Engineering, or related field

Tools

Veeva Vault

SAP

PAS-X

Computer System Validation (CSV)

Job description

Akaasa Technologies is seeking a hands-on pharmaceutical validation professional to support equipment, utilities and process validation within GMP systems. You will execute IQ/OQ/PQ protocols, manage deviations, and drive CAPAs while maintaining data integrity across validated systems.

The ideal candidate has 3+ years in pharma validation, strong regulatory knowledge (FDA/EMA/ICH/GAMP5), and collaborates with QA, QC, engineering, and manufacturing teams to ensure compliant, reliable operations.