Validation Engineer, Commercial Operations
Serán BioScienceBend, Oregon, United States
Posted January 23, 2025
Full-time Exempt
About the Company
Serán provides specialized drug development services, employing novel tech for poorly soluble compounds.
Job Description
Serán BioScience is seeking an experienced Validation Engineer to support the development of a new commercial manufacturing facility. The successful candidate will be responsible for developing and executing commissioning/qualification and validation studies in conformance with cGMPs and FDA requirements.
Requirements
- 5+ years of quality, validation, or engineering experience in non-sterile clinical and commercial pharmaceutical manufacturing
- Knowledge of cGMPs guidelines and regulations, Global Regulatory requirements (E.g., FDA / MHRA / EMEA)
- Foundational understanding of compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products
Benefits
- Over four weeks of paid time off annually
- Employer contributions to a retirement account
- Various health plans with minimal employee contributions
- Basic life and long-term disability coverage
- Employee Assistance Program
- Pet insurance
