Validation Engineer
Validation Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Requirements:
- 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.
- Bachelors degree in engineering Plastics Engineering Mechanical Engineering or related technical field.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
