Sr. Validation Engineer

Sr. Validation Engineer Design Group - 3.4 Indianapolis, IN Job Details Full-time 15 hours ago Qualifications Bachelor's degree in mechanical engineering CAD software 7 years Requirements specification Bachelor's degree in electrical engineering Technical documentation Pharmaceutical regulatory compliance Program development Engineering Bioengineering Bachelor's degree in biomedical engineering Mechanical Engineering Biomedical Engineering Client relationship development Technical report writing ICH Q9 Analysis skills Bachelor's degree in engineering Bachelor's degree Packaging HVAC Organizational skills Bachelor's degree in chemical engineering Productivity software Commissioning phase involvement Senior level Microsoft Project Leadership Communication skills Technical Proficiency Regulatory compliance management FDA regulations Engineering validation

Full Job Description 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:

Sr. Validation Engineer Who You'll Work With You will join one of our 45 offices in the US, be part of a committed team of over 1500 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 Sr. Validation Engineer , 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 expert s 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 project CQV delivery and individual technical contribution for our clients . Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

Validation & Compliance Activities:

Assist basic and conceptual design phases of capital projects by working with clients and vendors on embedding compliance, testability and lifecycle thinking into early design Establish User Requirement Specifications for critical equipment and systems. Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects. Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes - employing industry's most progressive Digital Validation Tools Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment Perform FAT, SAT, IQ, and OQ documentation development and execution on equipment/systems. Conduct investigations and troubleshoot validation-related issues Prepare comprehensive written validation reports.

What You'll Bring Experience Requirements :

Sr.

Validation Engineer:

Minimum 7+ years demonstrated experience with design, commissioning, validation of automation, packaging drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., asepti c filling, inspection) systems/equipment, utilities ( i . e ., proce ss , equip ment) , and/or facilities ( i.e., HVAC, cla ssificatio n , con taminati on control ) pharmaceutical or medical device environments validation Ext ensive hands -on expe rience wi th G M P-regula ted envir onment s with knowledge of regul ation and guidan ce ' s (i .e., CF R Parts 210 , 211, 11) , Ann ex 1 , ICH

Q 7 /Q 8 / Q9 , ISPE G2G

) E xperience with imp lement ing ris k -based approaches to v alidation pro jects Aut horing, review ing and approving Val idation Master P lans, risk assessmen ts, devi ation s , and change cont rols.

Technical Skills & Qualifications:

Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree) Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD) Experience with entire project lifecycle from concept development through startup (preferred)

Professional Attributes:

Excellent leadership and organizational skills with ability to manage multiple responsibilities Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors Flexibility with tasks and strong analytical capabilities Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events. Ab le to comm unicate and develop lon g-las ting rela tionships with client s and proje ct team s 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 Sr. Validation Engineer , you will build a meaningful and fulfilling career with the support of professional development resources and mentors hips 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 Feel like you're on the path to becoming a Sr. Validation Engineer , but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant. 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.

Company:

Design Group