Transformation Project Qualification Lead

What you'll do

• Develop User Requirements Specifications and Functional Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing to confirm that units are acceptable before deployment.
• Identify risk controls and critical elements of equipment design based on FMEA or other risk assessments.
• Develop and execute commissioning, qualification, and validation test protocols to ensure systems meet specifications.
• Perform minor troubleshooting of issues during commissioning and document unresolved problems for resolution.
• Lead the execution of Risk Management activities including periodic reviews and updates per the Validation Master Plan.
• Supervise contract validation resources to ensure timely completion of assigned activities.
• Manage multiple complex projects simultaneously while ensuring compliance with quality and regulatory standards.

What we're looking for

• Bachelor’s Degree in Engineering, science, or related discipline is desired, or equivalent technical experience plus demonstrated competence.
• 3+ years of significant engineering and/or operational experience (desired).
• Experience developing commissioning, qualification, validation, and risk management deliverables that meet regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality, or Engineering including 4 major validation subjects (preferred).
• Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug, or Finished goods manufacturing (preferred).
• Ability to manage complex projects and multiple projects (5+) simultaneously.
• Strong interpersonal, communication, and negotiation skills with the ability to work in a team environment.