Sr. Validation Engineer

What You’ll Do

• You’ll work individually and in teams to support capital project CQV delivery and individual technical contribution for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• 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 equipment/systems.
• Conduct investigations and troubleshoot validation‑related issues.
• Prepare comprehensive written validation reports.

• 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.

• 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).

• 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.