Process Validation Engineer

Katalyst Healthcares and Life Sciences

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.

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Vacancy posted 3 days ago

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