Associate Validation Engineer

Description

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. Develops 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:

• Bachelor’s Degree in Engineering, Life Sciences, or a closely related technical discipline (e.g., Chemistry, Biology, Physics, or Pharmaceutical Sciences).
• At least 2 years of direct validation experience in the pharmaceutical, biotechnology, or medical device industry.
• In lieu of a bachelor’s degree:
• Associate’s Degree + 2 years additional validation experience, or
• High School Diploma/equivalent + 4 years additional validation experience.
• Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Also requires understanding of cGMPs and basic validation / qualification concepts.
• Must be able to identify and understand critical functions and features of equipment and systems.
• Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new validation methodologies.
• Requires effective technical writing and oral communication skills to interact across all levels of the organization.
• This position is responsible to develop and execute validation protocols under defined guidelines.

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BioMérieux 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 BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).