BW Design Group · 1 day ago
Validation Engineering Roles
Columbia, MD
Full-time
Onsite
Mid, Senior Level, Lead/Staff, Director/Executive
2+ years expBW Design Group is a rapidly growing business with over 1500 professionals dedicated to delivering quality solutions in the Life Sciences industry. The Validation Engineer will support capital project CQV delivery and contribute technical solutions, focusing on validation and compliance activities for pharmaceutical equipment and processes.
Industrial Automation
No H1B
Responsibilities
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
Qualification
Required
Minimum 2-7 years project experience with validation of automation, packaging, utilities, and/or facilities in pharmaceutical or medical device environments (Validation Engineer II)
Minimum 7+ years demonstrated experience with pharmaceutical or medical device process and equipment validation (Sr. Validation Engineer)
Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications (Sr. Project Manager)
Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree)
Validation experience in automation, packaging, cleaning, 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
Must be legally authorized to work in the United states without sponsorship
Preferred
Experience with entire project lifecycle from concept development through startup
Company
BW Design Group
BW Design Group is the only independent, fully integrated AEC firm powered by a Manufacturer's Mindset™.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Aderito Dos Santos
Partner
Adolfo Santana
Partner Quality and Regulatory Compliance Consulting Services
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