Job Description:Who You'll Work WithJoin 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 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.
What You'll Do 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:
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 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: 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, packagingdrug 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.
- CSV Engineer: A minimum of four years of computer system validation experience in the pharmaceutical, biotech, medical device or other FDA regulated industries, Competency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessments Experience in generating software development life cycle documentation such as FRSs, SDSs, HDSs and configuration specifications Hands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software platform An understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipment
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.
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"Must be legally authorized to work in the United states without sponsorship"
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.
Company:Design Group
