Validation Engineering Roles

Barry-Wehmiller; Indianapolis (IN); On-site; Full time

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:

Validation Engineering Roles

Who You’ll Work With

Join one of our 45 offices in the US as part of a committed team of over 1500 professionals, working directly with clients on projects that shape the world around us. As a contract professional with BW Design Group,you’llbe welcomed into a rapidly growing business and empowered to make an immediate impact.You’llwork alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy.

What You’ll Do

You’llsupportbothcapital projectCQV delivery and individual technical contributionsolutions for our clientswithinthe Life Sciencesindustry. You’llhelp clientsimplementcritical changes to improve their performance and realize their most important goals through:

Validation & ComplianceActivities:

• 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


• EstablishUser Requirement Specifications for critical equipment and systems.


• Assess risk across various aspects ofsystems’ functionsandfocus 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 Automated Systems


• Conduct investigations and troubleshoot validation-related issues


• Prepare comprehensive written validation reports.

Project Management & Leadership :

• Lead all aspects of client relationship development and project execution


• Develop project plans, strategies, and manage project resources, budgets, and schedules


• Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup


• Manage multiple project responsibilities simultaneously with excellent organizational skills


• Focus on project success related to scope, schedule, budget, and client satisfaction

What You’ll Bring

Experience Requirements (Based on Role Level)

• Validation Engineer II: Minimum2-7yearsproject experience with validation of automation, packaging, drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments


• Sr. Validation Engineer: Minimum7+yearsdemonstratedexperience with design, commissioning, validation of automation, packaging drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments validation


• Sr. Project Manager: Minimum10+yearsproject engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications

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

#LI-TH1

“Must be legally authorized to work in theUnited stateswithout sponsorship”

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.

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