Validation Engineering Roles

Barry-Wehmiller • Indianapolis, IN

3d

About The Position

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'll be welcomed into a rapidly growing business and empowered to make an immediate impact. You'll work alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy. You'll support both capital project CQV delivery and individual technical contribution solutions for our clients within the Life Sciences industry. You'll help clients implement critical changes to improve their performance and realize their most important goals through:

Requirements

• Validation Engineer II: Minimum 2-7 years project 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: 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., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments validation
• Sr. Project Manager: Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications.
• 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.
• “Must be legally authorized to work in the United states without sponsorship”

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 Automated Systems
• Conduct investigations and troubleshoot validation-related issues
• Prepare comprehensive written validation reports.
• 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 This Job Offers

• Career Level: Mid Level