Senior Validation Specialist – GMP Equipment & Compliance

Creative Solutions Services, LLC; Manchester (NH); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in Manchester, NH, seeks a seasoned Validation Engineer to lead GMP equipment validation programs. You will execute IQ/OQ/PQ, perform cleaning validation, and support commissioning of new or modified systems while ensuring cGMP compliance.

With 5+ years of hands-on validation experience, you will generate validation documentation, manage change controls, investigations, and CAPAs, and assist in regulatory inspections.

Qualifications

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

Education

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

Job description

Creative Solutions Services, LLC in Manchester, NH, seeks a seasoned Validation Engineer to lead GMP equipment validation programs. You will execute IQ/OQ/PQ, perform cleaning validation, and support commissioning of new or modified systems while ensuring cGMP compliance.

With 5+ years of hands-on validation experience, you will generate validation documentation, manage change controls, investigations, and CAPAs, and assist in regulatory inspections.