BAS: Building Automation System
- East Coast, US, us
Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
- Development CSV report preparation, execution and engineering support for Extrusion System Equipment and Control Systems, hardware & software. Mostly PLC Allen Bradly and Siemens (S7-300 & S-IM151-8) and software for manufacturing area.
- Computer system validation (CSV).
- Validate new system and software for Information Virtualized OS server, OS clients and Batch server for its Intended purpose in compliance, requirements, and process specifications.
- The validation / qualification deliverables and related activities is performed:
• SOP revision; Risk Based Project Plan (RBP)
• User Requirement Specification (URS)
• Functional Design Specification (FDS) revision
• Revision System Design Specification (SDS)
• Development execution and CSV report preparation of the qualification/validation package IQ/OQ, SAT revision
- Bachelor's degree in Engineering (Computer, Chemical, Electrical, Mechanical or Industrial).
- Minimum of five (5) years of experience required in the medical device or pharmaceutical industry.
- Self-starter, able to prioritize multiple tasks to meet strict deadlines and have sufficient knowledge developing and conducting efficient processes to meet production demands.
- Ability to utilize six sigma tools for improvements and efficiencies.
- Excellent technical writing and verbal communication skills.
- Proficiency utilizing Minitab and the MS Office Suite (Word, Excel and PowerPoint) is required.
- Knowledge in regulations, including GMP, QSR, and ISO requirements is necessary.
- Excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills.
- Ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization is required.
- Fully bilingual (Spanish & English).
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.