Sr. Validation Engineer

Barry-Wehmiller•Indianapolis, IN

1d•Hybrid

About The Position

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. 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 experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Requirements

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., aseptic filling, inspection) systems/equipment, utilities (i.e., process, equipment), and/or facilities (i.e., HVAC, classification, contamination control) pharmaceutical or medical device environments validation
Extensive hands-on experience with GMP-regulated environments with knowledge of regulation and guidance's (i.e., CFR Parts 210, 211, 11), Annex 1, ICH Q7/Q8/Q9, ISPE G2G)
Experience with implementing risk-based approaches to validation projects
Authoring, reviewing and approving Validation Master Plans, risk assessments, deviations, and change controls.
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)
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.
Able to communicate and develop long-lasting relationships with clients and project teams

Nice To Haves

Experience with entire project lifecycle from concept development through startup (preferred)

Responsibilities

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.