Validation Engineer

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.