What are the responsibilities and job description for the Validation Engineer position at Intellectt Inc?
Role: Validation Engineer
Location: Holdridge, NE
Duration: 2 years - Contract
**Onsite - W2/1099 Only - No C2C**
Job Summary:
The Validation Engineer will execute and implement validation initiatives for Project Pearl, supporting Quality Engineering and Quality Systems teams. This role ensures compliance with regulatory standards and internal quality policies while fostering technical and organizational competence within the plant.
Key Responsibilities:
- Provide technical expertise to product initiatives and resource planning.
- Support Project Pearl with quality engineering tools, including root cause analysis, FMEAs, risk mitigation, validation, and process improvement techniques.
- Develop and implement solutions for routine quality and validation challenges.
- Ensure adherence to regulatory, corporate, and site-specific quality requirements.
- Collaborate with cross-functional teams on product development and sustaining engineering projects.
- Identify and document continuous improvement opportunities through data analysis and process control monitoring.
- Approve validation protocols and reports in line with established procedures.
- Apply Lean and Six Sigma methodologies for validation and continuous improvement efforts.
Qualifications:
- Education: B.S. degree required (Engineering preferred).
- Experience: 3 years in Quality Engineering and Validation.
- Proficiency in statistical software (e.g., Minitab), MS Office tools, and project management.
- Strong knowledge of quality engineering principles, failure analysis, and regulatory standards (21CFR820, ISO 13485).
- Desired certifications: Six Sigma, ASQ CQE.
