- Location
- Bend, Oregon
- Workplace
- Onsite
- Type
- Full-time
- Department
- Quality
- Seniority
- Senior
- Experience
- 1+ years
- Education
- Bachelor
- Industry
- Pharmaceuticals
- Category
- Engineering
- Role type
- People Manager
- Environment
- Industrial
- Source
- Lever
Overview
As a Laboratory Instrumentation and Validation Specialist at Serán, you'll be responsible for onboarding, maintaining, troubleshooting, repairing, and validating laboratory instruments and associated computerized systems within a regulated GMP environment. You'll lead a small technical team, ensuring effective task execution and clear communication. Key responsibilities include instrument onboarding, installation, qualification, computer system validation activities, troubleshooting laboratory instruments, coordinating repairs and preventive maintenance, supporting calibration programs, and maintaining documentation. The role requires a bachelor's degree in chemistry, engineering, or related field, 3-5 years of hands-on experience with analytical instrumentation (HPLC, dissolution, balances, FTIR), and 1-2 years in a lead/supervisory position. You'll also need knowledge of cGMP, 21 CFR Part 11, and regulatory guidelines from FDA, EU, and ICH.
