What are the responsibilities and job description for the Validation Specialist position at Intellectt Inc?
Role: Validation Engineer
Location: Albany, NY - Hybrid
**Only W2/1099 - No C2C - H1B/GC sponsorship available**
We are seeking a skilled Validation Engineer to join our client’s team in the pharmaceutical industry. This role ensures that all equipment, systems, and processes meet regulatory and quality standards to support manufacturing excellence.
Key Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and processes.
- Conduct risk assessments and gap analyses to ensure compliance with cGMP and FDA requirements.
- Perform validation testing, troubleshoot issues, and implement corrective actions as needed.
- Maintain and update validation documentation, including reports and summaries.
- Support regulatory inspections and audits by providing validation-related documentation and expertise.
- Collaborate with cross-functional teams to support continuous improvement initiatives.
Required Experience:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 5 years of experience in validation within the pharmaceutical or biotech industry.
- Strong knowledge of cGMP, FDA, and industry standards (e.g., ISO 13485).
- Proficiency in risk assessment methodologies (e.g., FMEA) and validation lifecycle management.
- Excellent problem-solving, analytical, and communication skills.
