Principal Engineer, Pharmaceutical Manufacturing

The International Society for Pharmaceutical Engineering, Inc.; Sandy (UT); On-site; USD 120,000 - 180,000; Full time

Job summary

BD is seeking an experienced Project Engineer/Manager to lead capital and process improvement projects in a regulated drug manufacturing environment at our Sandy, Utah site.

You will develop charters, schedules, and budgets; lead cross-functional teams; ensure IQ/OQ/PQ validation; manage change control; and drive Lean/Six Sigma improvements in CFR 21 contexts.

Applicants should have a Bachelor’s degree in Engineering and 8+ years of relevant experience.

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 IQ/OQ/PQ validation.
• Experience with plant utilities (HVAC, compressed air, power) in manufacturing.
• Experience in Change Control processes and QMS.
• Experience managing large capital project budgets ($1M+).
• PMP certification is a plus.

Responsibilities

• Lead and manage concurrent large-scale capital and process improvement projects in an FDA-regulated drug environment.
• Develop project charters, scopes, schedules, budgets, and resource plans.
• Lead cross-functional teams and ensure accountability.
• Develop IQ/OQ/PQ documentation and ensure compliance with FDA validation requirements.
• Manage change controls and CAPAs through site QMS.
• Develop, track budgets, and forecast expenditure; manage purchase orders.
• Maintain detailed project schedules, identify risks, and implement mitigation plans.
• Provide regular status updates to plant leadership and stakeholders.
• Ensure compliance with CFR 21 and EHS standards; drive Lean/Six Sigma improvements.
• Identify and lead continuous improvement initiatives to improve safety, quality, throughput, and cost.

Skills

Project leadership

Cross-functional coordination

Regulatory & safety compliance

Change control

Budget & cost control

Schedule & risk management

Reporting & stakeholder engagement

Lean & Six Sigma

Documentation & validation

Leadership without authority

Education

Bachelor’s degree in Engineering

PMP certification (preferred)

Tools

MS Office

Project management software

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job Responsibilities:

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 elevate 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.

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

Technical Knowledge and Skills:

• 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.

Work Environment

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.

Why Join Us?

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.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift