Validation Specialist

Katalyst-Healthcares-; Nashua (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst-Healthcares- in Nashua, NH, seeks an experienced validation professional to drive GMP equipment validation and related activities. You will support cleaning validation, IQ/OQ/PQ, and documentation across the validation lifecycle.

The role requires 5+ years hands-on experience, strong knowledge of cGMP/GDP, and collaboration with Engineering and Operations to ensure compliant execution and timely inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline is required.
• 5+ years of hands-on validation experience with GMP equipment and utilities.

Responsibilities

• Support cleaning validation activities, protocol execution, sampling, and documentation.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
• Support commissioning, installation, and qualification of new or modified equipment.
• Assist with equipment troubleshooting alongside Engineering and Operations.
• Generate validation documentation following cGMP, GDP, and SOP requirements.
• Support validation lifecycle activities, change controls, investigations, and CAPAs.
• Participate in audit readiness and regulatory inspection support.

Skills

Validation

Documentation

Audits readiness

Temperature mapping

CAPA investigations

GMP compliance

IQ/OQ/PQ concepts

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Tools

IQ/OQ/PQ processes

Job description

Requirements:

• Support cleaning validation activities, protocol execution, sampling, and documentation.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
• Support commissioning, installation, and qualification of new or modified equipment.
• Assist with equipment troubleshooting alongside Engineering and Operations.
• Generate validation documentation following cGMP, GDP, and SOP requirements.
• Support validation lifecycle activities, change controls, investigations, and CAPAs.
• Participate in audit readiness and regulatory inspection support.
• Bachelor's degree in Engineering, Life Sciences, or related discipline required.
• 5+ years of hands-on validation experience with GMP equipment and utilities.