Validation Engineering Roles

What You'll Do

• Support both capital project CQV delivery and individual technical contribution solutions for our clients within the Life Sciences industry.
• Help clients implement critical changes to improve their performance and realize their most important goals through:
• Validation & Compliance Activities: 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.
• 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, utilities, and/or facilities in pharmaceutical or medical device environments. Sr. Validation Engineer: Minimum 7+ years demonstrated experience with pharmaceutical or medical device process and equipment validation. Sr. Project Manager: Minimum 10+ years project 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, 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). 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.