Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Pharmaceutical, Medical Devices, Chemicals (API), Food, and Cosmetics industries.  For over twenty years, V&EG has placed the most talented individuals in a position to make a difference in our customer’s success.  Our services platform is split into four distinct areas: Regulatory Compliance, Validation and Qualification, Laboratory (Validation, Audits), and Engineering (Design Qualification Services), that ensure adherence to Federal and European regulatory agencies.

Support CSV Lifecycle:
• Functional Specification
• Design Specifications
• Development and execution of qualification protocols
• Summary Reports
Resource should have previous experience with automation (e.g. BAS- Building Automation Systems).

▪ General Support to IS/Automation site group in documentation, execution and contractor’s management during projects timeline.

▪ VP, IOQ, RTM, VSR, development and execution for Metasys 9.0.1 server and software update.

▪ Stand Alone equipment data integrity assessment development and execution.

▪ Commissioning and Qualification protocol execution for SCADA system for new inspection and packaging line. 

▪ Commissioning and Qualification Report generation for new SCADA system. 

▪ Gowning Room environmental performance qualification.

▪ Commissioning for two (2) new Air Handling Unit for a Raw Material and Spare Part Cold Room.

▪    Commissioning of new syringe inspection line execute site acceptance test (SAT) for the new Kyoto DE-Nester Machine and Autotrayer Machine, support during the characterization process of the line, support during the line integrated site acceptance test (SAT), support during the Installation and Operational Qualification (IOQ) execution.

▪    Update and generate requirement design documents for a new computer of a Diosna Granulation Train system.

▪    Plant Utilities and Qualified Building Management System data gathering to transfer data to Plant Information System (PI) for evaluation and cost reduction of the site.

▪    Generate and execute protocols for utilities PLC replacement.

▪    General validation and commissioning support for review and approve documents such as SAT, RD, RS, DS, IOQ, IOQ Report and RTM.

▪    Commissioning of a new serialization packaging line (Advisor/ Sentri).

▪    Purified Water System integration to PCS and PI System.

▪    Complete Validation (SAT, BMS Verification, IOQR) of new equipment on site (-300 Freezer)

▪    Commissioning execution for new and transfer equipment (Fermenter tank, Centrifuge, Purification Tanks, Oxidation Tanks, Filters)

▪    Review, Data Verifier and Approve commissioning documentation for new and transfer equipment (Fermenter tank, Centrifuge, Purification Tanks, Oxidation Tanks, Filters)

▪    Experience creating, developing and executing System Life Cycle (SLC) documentation for automated equipment/systems, SOP’s, Validation Master Plans (VMP), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR).

▪    Creating and executing Data and Security Integrity Assessment for standalone manufacturing equipment such as Vial Washer, Vial Capper, Ultrasonic Sink, CIP, Autoclave, Paperless recorders, Kaye.

▪    Creating and executing IOQ to down flow booth system, Refrigerant Leak detection system, and Potable and Sanitary Water Consumption system.

▪    Data verifier of Water Still system, Syringe Vision Inspection system.

▪    Creating and executing validation protocols (IQ, OQ, VSR) for PCS system.

▪    Creating SOP’s for new process.

▪    CAPA’s implementation process management.

▪    Create, update and review SAT and RD for BMS and PCS system.

• BS Computer Sciences, Engineering
• Fully Bilingual 

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.