Lead Principal Engineer, Pharma Manufacturing Projects

Becton Dickinson; Utah; On-site; USD 120,000 - 180,000; Full time

Job summary

Becton Dickinson (BD) is seeking a seasoned Project Engineer/Manager to lead large-scale capital and process-improvement initiatives in a regulated drug manufacturing environment. You will drive project charters, schedules, and budgets while coordinating cross-functional teams and ensuring compliance with IQ/OQ/PQ validation and FDA requirements.

Ideal candidates bring 8+ years of PM/engineering experience, strong Lean Six Sigma background, and expertise in Change Control and QMS.

Qualifications

• Requires a Bachelor’s degree in Engineering and 8+ years of project engineering/PM in a regulated drug manufacturing environment.
• Experience writing and executing IQ/OQ/PQ and validation activities.
• Experience with plant utilities (HVAC, compressed air, power) as they relate to equipment projects.
• Knowledge of Change Control processes and Quality Management Systems (QMS).
• Experience managing large capital project budgets of $1M+.

Responsibilities

• Lead and manage concurrent large-scale capital and process improvement projects end-to-end in an FDA-regulated drug environment.
• Develop project charters, scopes, schedules, budgets, and resource plans; use standard PM tools.
• Coordinate cross-functional teams; assign actions and track progress.
• Develop IQ/OQ/PQ documentation and ensure compliance with validation requirements.
• Manage change controls and CAPAs through site QMS.
• Forecast expenditure and manage capital/expense budgets with finance.

Skills

Project management

Cross-functional leadership

Lean Six Sigma

cGMP knowledge

FDA CFR 21 familiarity

MS Office Suite

Education

Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial)

Tools

MS Project

Project management software

Job description

Becton Dickinson (BD) is seeking a seasoned Project Engineer/Manager to lead large-scale capital and process-improvement initiatives in a regulated drug manufacturing environment. You will drive project charters, schedules, and budgets while coordinating cross-functional teams and ensuring compliance with IQ/OQ/PQ validation and FDA requirements.

Ideal candidates bring 8+ years of PM/engineering experience, strong Lean Six Sigma background, and expertise in Change Control and QMS.