Validation Engineer II

Barry-Wehmiller Companies Inc.; Indianapolis (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Barry-Wehmiller Design Group in Indianapolis is seeking a Validation Engineer II to support capital projects, developing validation and FDA-compliance documents for pharmaceutical equipment and processes.

You will collaborate with cross-functional teams, perform risk assessments, design qualification plans, execute protocols, and contribute to project planning and client communication.

Qualifications

• Minimum 3 years project experience in pharmaceutical or medical device environments.
• Strong technical writing and clear oral communication.
• Willingness to travel to client sites for installation and startup activities.
• Understanding of ICH Q7–Q11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, ASTM E2500.
• BS in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Responsibilities

• Develop and execute validation and FDA compliance documents for pharmaceutical equipment and processes.
• Assess risk, create qualification plans, and perform investigations and troubleshooting.
• Prepare validation reports and support project planning, scheduling, and client communication.

Skills

Communication skills

Interpersonal skills

Technical writing

Team player

Travel willingness

Education

BS in Bioengineering or related technical field

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

## Validation Engineer IIApplylocations: Indianapolis, INtime type: Full timeposted on: Posted 8 Days Agojob requisition id: R022175**About Us:**BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.**Job Description:****Validation Engineer II****Who You’ll Work With**You will join one of our 45 offices in the US, be part of a committed team of over 1600 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a 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-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.When you join Design Group as a Validation Engineer II, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.**What You’ll Do**You'll work individually and in teams to support capital projects and implement solutions for our clients. 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 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.* Establish user requirement specification for critical equipment and systems* Assess risk across various aspects of systems’ functions and focus efforts on critical quality aspectsDevelop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes including: Process Equipment, Facility / Utilities, Cleaning / Process* Work with teams to perform investigations and troubleshoot issues related to validation* Analyze qualification data and recommend corrective actions* Develop & perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables* Prepare validation reports* Assist in project planning, scheduling, and coordination* Provide routine communication and status updates to BW Design Group project leadership and the client. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team**What You’ll Bring*** 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* Ability to work as an individual contributor as well as a team player on a large project team* Minimum of 3 years project experience in the pharmaceutical or medical device environments* 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 not limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.* Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME2500* 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. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Validation Engineer II, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.#LI-TH1*At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. *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.