Associate Validation Engineer

The Associate Validation Engineer will develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments. Develop and executes equipment, cleaning, and process validation protocols including statistical analysis of data generated by validation studies.

Primary Duties

1. Write and execute validation protocols and test cases. Develops and executes equipment, cleaning, and process validation protocols including statistical analysis of data generated by validation studies and compiling relevant documentation. Execute validation projects, including deliverables, timelines, materials, etc., to support site initiatives.
2. Assure validation documentation is generated and reviewed in accordance with site procedures.
3. Provide support of change control processes by performing qualification or re-qualification activities as needed. Support CAPA, investigations, Waivers as applicable.
4. Ensure validated state is maintained by performing periodic review of equipment and processes on time.
5. Revise and update validation SOPs and Site Validation Master Plan as required.
6. Ensure all assigned items on the requalification schedule are performed on time.
7. Continuously improve and update the validation program.
8. Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
9. Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Minimum Requirements:

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BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).