Transformation Project Qualification Lead, API

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 installation.
• 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 during commissioning and document any unresolved issues for further resolution.
• Lead the execution of Risk Management including periodic reviews and updates per the Validation Master Plan.
• Supervise contract validation resources to ensure timely completion of activities within your area of responsibility.

What we're looking for

• Bachelor’s Degree in Engineering, science, or a related field is desired, or equivalent technical experience and competence.
• At least 3 years of significant engineering and/or operational experience are desired.
• 6+ years of overall experience in Manufacturing, Quality, or Engineering is preferred.
• Experience in at least 4 major validation subjects such as Computer, Equipment, Cleaning, or Process is preferred.
• Experience developing commissioning, qualification, validation, and risk management deliverables that meet regulatory scrutiny.
• A technical background in pharmaceutical, medical device, or similar industries is preferred.
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug, or Finished goods manufacturing is preferred.
• Ability to manage complex projects and multiple projects simultaneously while supervising junior or contract team members.