Process Validation Engineer
Karwell TechnologiesIndianapolis, IN
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Overview
Remote
On-site
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.
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FAQs About Process Validation Engineer Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Indianapolis, IN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
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