Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world’s leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our 1,500-plus technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
The Validation Engineer will be 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.
FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
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
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
Co-op or project experience with validation of automation, packaging, utilities and/or facilities is desired
Co-op or project experience in the pharmaceutical or medical device environments is a plus
Strong technical writing and oral communications
Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
Ability to travel up to 60% nationally or regionally to support installation and start-up activities, attend Client meetings, Design Group management meetings, company sponsored training and industry related seminars, forums or conventions
B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.
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.
Nationally. Please see our site for an updated list of office locations.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.