Senior Validation Engineer

About the role

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

What You’ll Do

• Work individually and in teams to support capital project CQV delivery and individual technical contribution for our clients.
• Help our clients make critical changes to improve their performance and realize their most important goals.
• Validation & Compliance Activities:
  • Aid in the basic and conceptual design phases of capital projects by working with clients and vendors on embedding compliance, testability, and lifecycle thinking into early design.
  • Create 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.
  • Conduct investigations and troubleshoot validation-related issues.
  • Prepare comprehensive written validation reports.

What You’ll Bring

• Experience 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.
• Technical Skills & Qualifications: Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree).
• 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.
• Able to communicate and develop long-lasting relationships with clients and project teams.