Principal Engineer, Pharmaceutical Manufacturing

Job Title

Project Leadership Engineer

Project Leadership:
Lead and manage concurrent large-scale capital and process improvement projects end-to-end in an FDA regulated drug environment. Primary projects include revising the layout and process flow for existing production areas and assuring the associated operations and manufacturing spaces are CFR title 21 compliant.

Project Planning & Execution:
Develop project charters, scopes, schedules, budgets, and resource plans. Use industry standard project management tools for project execution.

Cross-Functional Coordination:
Lead and coordinate diverse cross-functional teams. Assign actions to resources, follow up on tasks and hold team members accountable.

Validation and Compliance:
Develop and manage IQ/OQ/PQ documentation, and ensure all equipment and process changes meet BD and FDA validation requirements.

Change Control:
Manage change controls and CAPAs related to project activities through site QMS (Quality Management System).

Budget and Cost Control:
Develop, track, and report on capital and expense budgets. Manage purchase orders and collaborate with finance to accurately forecast expenditure.

Schedule and

Risk Management:

Maintain detailed project schedules, proactively identify risks, develop mitigation plans, and escalate issues as needed.

Reporting and Stakeholder Engagement:
Provide regular status updates to plant leadership and stakeholders. Report on successes and opportunities for improvement.

Regulatory and Safety Compliance:
Ensure all engineering designs, installations, and modifications comply with applicable codes, FDA regulations, and corporate BD Environmental Health and Safety (EHS) standards.

Continuous Improvement:
Identify and lead continuous improvement initiatives (Lean, Six Sigma) to improve safety, quality, throughput, and cost performance.

• 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+.

• Project Management Professional (PMP) certification

• Demonstrated track record of successfully managing multiple capital projects simultaneously from concept through validation.
• Knowledge of drug manufacturing regulations within FDA CFR 21 including cGMP standards.
• Strong working knowledge of FDA drug manufacturing regulations within FDA CFR 21.
• Proficiency in project management software/tools and MS Office Suite.
• Excellent organizational, communication, and leadership skills with the ability to influence cross-functional teams without direct authority.
• Strong analytical and problem-solving skills.
• Adept at managing competing priorities across multiple projects
• Familiarity with Lean manufacturing, Six Sigma, and other continuous improvement methodologies
• Working knowledge of technical drawings, equipment layouts, and schematics.
• Capable of creating thorough document strategies and experience submitting ECOs for updating SOPs, BOMs, etc.

Personal Protective Equipment (PPE) must be worn in production areas and may include; hair nets, steel toe shoes, safety glasses, and earplugs.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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