Validation Engineer
Gurnee, IL 60048 US
Job Description
Job Summary:
The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment.
Job Duties:
- Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Qualification Policies.
- Initiate Change Controls - provide validation assessments and remediation plans as required by the system/equipment/components.
- Develop Commissioning and Qualification Plans.
- Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211, as well as adherence to ICH Q7.
- Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
- Assure Compliance with FDA and EU Regulations.
- Evaluate, document, and develop investigations attributed to qualifications failures.
- Author Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- Assure all the qualification items are tracked and successfully completed.
- Perform GAP analysis and provide recommendations for existing qualifications.
- Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)
Qualifications:
- Bachelor’s or Master’s Degree in a related Engineering field.
- 2+ years of experience with commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.