Process Validation Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 95,000 - 130,000; Full time

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.

Skills

Process Validation

Equipment Qualification

CSV (Computer Systems Validation)

Temperature Mapping

GMP/cGMP Compliance

CAPA & Change Control

Documentation

Communication

Problem Solving

Education

Bachelor's degree in Engineering, Science, or related field

Tools

Kneat

Ellab

Job description

Job Description

We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance.

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.

Requirements

• Bachelor's degree in Engineering, Science, or a related field.
• Experience in process validation, equipment qualification, or validation engineering.
• Knowledge of IQ/OQ/PQ and validation lifecycle activities.
• Familiarity with CSV principles and regulatory requirements.
• Experience with Kneat, Ellab, or similar validation tools is preferred.
• Understanding of GMP/cGMP regulations.
• Strong documentation, communication, and problem-solving skills.

Preferred Skills

• Process Validation.
• Equipment Qualification.
• CSV (Computer Systems Validation).
• Temperature Mapping.
• Kneat.
• Ellab Systems.
• GMP/cGMP Compliance.
• CAPA and Change Control.