Validation Engineer

Validation Engineer

WhoYou’llWork With

You will join one of our 45 offices in the US, bepart of a committed team ofover1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed intoa rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-classprofessional consultantandsurrounded byleaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as aValidation Engineer II,you are joining a team that will challenge you andposition you for growth. In this role, you will work witha team ofindustry experts to helpthe world’s leading companiessolve their most difficult problems. You willjoin ourRegulatory Compliance Practiceandpartner with seasoned leaders, technicalspecialists, and subject matter expertsto deliver the highest quality solutions to our clients with consistency and accuracy.

WhatYou’llDo

You'llwork individually and in teams tosupport capital projectsand implement solutionsfor ourclients.Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• 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 toassistin the design of manufacturing processes, help manage projects, develop facilities, andimpactthe 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 familymember allwhile expanding your technical abilities.

• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry

• Assistin 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

• Make an impact day-to-day with your skills andexpertise, strengthening that relationship with our clients and team

WhatYou’llBring

• Candidates need topossessgood communicationand interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors

• Minimum of 3 yearsproject experience with validation of automation, packaging,utilitiesand/or facilities

• Minimum of 3 yearsproject experience in the pharmaceutical or medical device environments

• Authoring CAPA's, deviations, SOP's is a plus

• Strong technical writing and oral communications 

• Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)

• Willing and able to travel as necessary for project requirements to include but notbe limitedto project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Our culture and commitment to our people is what sets us apart.We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Ourmodel and entrepreneurial mindsetoffer a rewarding, challenging, andhighlyflexible path. As aValidation Engineer II, youwill build a meaningful and fulfilling careerwith the support of professional developmentresourcesand mentorshipsincludingourFirst Year Experience program, Individual Development Plans, and Career Pathresourcesand tools.You willbe surrounded by exceptional talentwho will supportyour development as both a world-class engineer andahighly effective leader.