What are the responsibilities and job description for the Process Validation Engineer position at Katalyst CRO?
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
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.
- 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.
- Process Validation.
- Equipment Qualification.
- CSV (Computer Systems Validation).
- Temperature Mapping.
- Kneat.
- Ellab Systems.
- GMP/cGMP Compliance.
- CAPA and Change Control.