What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Responsibilities
- Lead validation efforts for injection molding machines, auxiliary equipment (e.g., dryers, chillers, robots), and integrated automation systems.
- Develop and execute validation protocols (SAT, FAT, IQ, OQ, PQ) for molding and downstream equipment.
- Support the qualification of new production lines involving injection-molded components.
- Perform process characterization, capability studies, and stability testing for moulded parts.
- Collaborate with tooling, manufacturing, and quality teams to troubleshoot process issues and support process optimization.
- Prepare and maintain validation documentation, including risk assessments, protocols, and summary reports.
- Conduct temperature/humidity mapping of controlled areas and qualification of cleanroom equipment as needed.
- Coordinate activities across both Buffalo Grove and Libertyville facilities to support project milestones.
- 5 years of validation experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
- Direct experience with injection molding validation, including equipment qualification, process validation, and part testing.
- Proficiency with automated manufacturing systems, including HMI/PLC controls.
- Strong understanding of cGMP, FDA 21 CFR Part 11, ISO 13485, and GAMP 5 guidelines.
- Demonstrated ability to work independently and manage multiple validation projects across facilities.
- Experience with cleanroom and environmental system validation (ISO Class 69)'
- Familiarity with SCADA systems, data loggers, and equipment calibration tools.
- Experience validating downstream automation equipment such as conveyors, vision systems, or packaging lines.
- Bachelor's degree in engineering, Plastics Engineering, Mechanical Engineering, or related technical field.
