Principal Engineer, Pharmaceutical Manufacturing

Job 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 industry standard project management tools for project execution.
• Lead and coordinate diverse cross-functional teams.
• Assign actions to resources, follow up on tasks and hold team members accountable.
• Develop and manage IQ/OQ/PQ documentation, ensuring all equipment and process changes meet BD and FDA validation requirements.
• Manage change controls and CAPAs related to project activities through site QMS (Quality Management System).
• Develop, track, and report on capital and expense budgets.
• Manage purchase orders and collaborate with finance to accurately forecast expenditure.
• Maintain detailed project schedules, proactively identify risks, develop mitigation plans, and escalate issues as needed.
• Provide regular status updates to plant leadership and stakeholders.
• Report on successes and opportunities for improvement.
• Ensure all engineering designs, installations, and modifications comply with applicable codes, FDA regulations, and corporate BD Environmental Health and Safety (EHS) standards.
• Identify and lead continuous improvement initiatives (Lean, Six Sigma) to improve safety, quality, throughput, and cost performance.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline)
• 8 years of project engineering/project management experience in a regulated drug manufacturing environment.
• Experience with writing and executing equipment installations and process validation (IQ/OQ/PQ).
• Experience implementing infrastructure changes including plant utilities (HVAC, compressed air, power, etc.) as they relate to manufacturing equipment projects and process layout changes.
• Experience in Change Control processes and Quality Management Systems (QMS).
• Experience managing large scope, high capital project budgets ranging from $1M+.

Preferred Qualifications

• Project Management Professional (PMP) certification.