GMP Validation Engineer - CTU/Equipment

Intellectt INC; Harmans (MD); Presencial; USD 45 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance

Retirement Plan (401k)

Paid Time Off

Resumo da oferta

Intellectt Inc. is seeking a Validation Engineer in Harmans, MD to support GMP/GDP regulated pharma/biotech projects. You will map CTU temperatures, qualify equipment, and develop validation documentation in an onsite W2 contract role.

The ideal candidate has 2–5+ years of GMP-regulated experience and hands-on qualification expertise. The position emphasizes adherence to site procedures and timely validation reporting.

Qualificações

• 2–5+ years GMP-regulated pharma/biotech experience.
• Hands-on CTU temperature mapping and equipment qualification experience.
• Experience reviewing deviations, change controls, EMS trends and alarms.

Responsabilidades

• Execute temperature mapping for CTUs and equipment across multiple units.
• Develop and execute validation and requalification protocols.
• Prepare and review validation reports and qualification documents.
• Review deviations, change controls, EMS trends, and alarms.
• Ensure GMP/GDP compliance and site procedures.

Conhecimentos

CTU Temperature Mapping

Equipment Qualification

Requalification

GMP/GDP

Validation Documentation

Descrição da oferta de emprego

Intellectt Inc. is seeking a Validation Engineer in Harmans, MD to support GMP/GDP regulated pharma/biotech projects. You will map CTU temperatures, qualify equipment, and develop validation documentation in an onsite W2 contract role.

The ideal candidate has 2–5+ years of GMP-regulated experience and hands-on qualification expertise. The position emphasizes adherence to site procedures and timely validation reporting.