Validation Engineer

Position : Validation Engineer

Location : Portsmouth NH

Summary :

Equipment Validation Specialist role ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements process parameters and global regulatory guidelines. The role provides Operations Quality Assurance and regulatory bodies with scientifically sound documented evidence that systems and processes will perform as required so they can be assured of a quality compliant manufacturing environment.

Responsibilities :

• Provide Subject Matter Expert support to Quality Control Manufacturing and other departments for the design operation and troubleshooting of equipment.
• Drive / own the validation plans and execution of equipment changes and process improvements.
• Execution of Installation Qualifications / Operational Qualifications and drafting Performance Qualifications asrequired.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in validated state.
• Program organize and maintain Validation equipment and supplies including dataloggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV / IQ) SteamInPlace (SIP)Autoclaves Clean Utilities Shipping Validation Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs Protocols Change Controls Deviations CAPA etc.
• Perform assigned Quality Systems activities within Document Management System (DMS) Laboratory InformationManagement System (LIMS) and TrackWise Quality System

Key Skills

Python,SOC,Debugging,C / C ,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Vacancy : 1