What are the responsibilities and job description for the Validation Engineer position at United Pharma Technologies Inc?
Role: CSV Engineer – Laboratory Instruments & GxP Compliance
Location: Indianapolis, IN (Onsite)
Summary:
CSV Engineer to support validation and qualification of laboratory analytical instruments in a GMP environment. The role includes computer system validation, software configuration, compliance activities, and lifecycle support.
Key Responsibilities:
- Perform CSV and lab instrument qualification (IQ/OQ/PQ) and documentation
- Manage system access, upgrades, and periodic/audit trail reviews
- Support software installation/configuration and IT infrastructure needs
- Develop SOPs and support data integrity initiatives
- Collaborate with internal teams and vendors on validation activities
Qualifications:
- 5 years of CSV experience with lab analytical instruments
- Strong knowledge of 21 CFR Part 11 and GMP labs
- Experience with GMARS, TrackWise, and Kneat
- Strong communication and organizational skills
Education:
- Bachelor’s degree in a related scientific, engineering, or computer science field