Validation Engineer

Overview

Develop and execute validation and FDA compliance documents for pharma equipment

Key Responsibilities

• fat/sat
• iq/oq
• validation docs
• fda compliance
• qms procedures
• investigation

Tasks

-FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry -Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team -Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. This person will travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals. This role will challenge you to be a passionate and successful business family member all while expanding your technical abilities. -Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10 -Work with teams to perform investigations and troubleshoot issues related to validation -Prepare written validation reports

Requirements

• autocad
• ms project
• bioengineering
• 3 years
• pharma
• technical writing

What You Bring

-Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) -B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree. -Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities is desired -Experience in a gown-room environment is a plus -Willing and able to travel as necessary for project requirements to include but not be limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc. -Strong technical writing and oral communications -Minimum of 3 years project experience in the pharmaceutical, biotechnology, or medical device environments is a plus -Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors

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About Bw Design Group

-Provides cutting-edge software tools and professional services for network design and optimization. -Recognized for versatility across industries, from telecommunication to utility networks. -Dedicated to continuous innovation and enhancement of customer value.

Sector Specialisms

Security Clearance

-may include drug screening -reference checks -employment verifications -background screening -skills assessments