Process Validation Engineer — GMP & CSV Specialist

Katalyst CRO

Indianapolis (IN)

On-site

USD 95,000 - 130,000

Full time

2 days ago

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Job summary

Katalyst CRO is seeking a Process Validation Engineer to support validation and qualification activities in a GMP-Regulated manufacturing setting. You will work on IQ/OQ/PQ/PPQ, CSV, and temperature mapping to ensure regulatory compliance across projects.

This role requires a strong background in process validation and equipment qualification, with knowledge of GMP/cGMP. You will collaborate with Engineering, Manufacturing, Quality, and Regulatory teams to drive CQV programs and improve quality

Qualifications

Bachelor's degree in Engineering, Science, or a related field.
Experience in process validation, equipment qualification, or validation engineering.
Familiarity with IQ/OQ/PQ and validation lifecycle activities.
Knowledge of GMP/cGMP regulations and CSV principles.

Responsibilities

Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ).
Develop, review, and maintain validation protocols and reports.
Support Computer Systems Validation (CSV) activities.
Perform temperature mapping studies and analyze validation data.
Utilize Kneat or similar electronic validation management systems.
Support commissioning, qualification, and validation (CQV) projects.
Investigate deviations and support CAPA and change control activities.
Ensure compliance with GMP, FDA, and regulatory requirements.
Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams.