Senior Engineer, Pharma Manufacturing & Process Improvement

BD; Sandy (UT); On-site; USD 120,000 - 180,000; Full time

Job summary

BD in Sandy, Utah is seeking a seasoned Project Engineer to lead large-scale capital and process improvement projects within a CFR 21 compliant environment. You will manage scopes, budgets and cross-functional teams, ensuring IQ/OQ/PQ validation of equipment and processes.

Responsibilities include change control, CAPAs, and tight cost management, while maintaining schedules and reporting to plant leadership. Prior experience with Lean/Six Sigma is preferred and exposure to QMS is required.

Qualifications

• Bachelor’s degree in Engineering or related discipline.
• 8+ years of project engineering/PM experience in a regulated drug manufacturing environment.
• Experience with IQ/OQ/PQ and equipment installations.
• Experience in Change Control processes and Quality Management Systems (QMS).
• Experience managing large capital project budgets ($1M+).
• CFR 21 / cGMP knowledge and drug manufacturing regulations.

Responsibilities

• Lead end-to-end capital and process improvement projects in an FDA-regulated drug environment.
• Develop project charters, scopes, schedules, budgets, and resource plans.
• Coordinate diverse cross-functional teams and track actions.
• Develop IQ/OQ/PQ documentation and ensure validation for equipment and processes.
• Manage change controls and CAPAs through the site QMS.
• Develop and monitor budgets; coordinate with finance on forecasted expenditure.
• Maintain detailed project schedules and identify risks with mitigation plans.
• Provide regular status updates to plant leadership and stakeholders.
• Ensure compliance with applicable codes, FDA regulations, and BD EHS standards.

Skills

Project leadership

Cross-functional leadership

Regulatory compliance

Communication

Analytical problem solving

Lean Six Sigma

Change management

Risk management

Education

Bachelor’s degree in Engineering

Tools

MS Office Suite

Project management software

QMS software

Job description

BD in Sandy, Utah is seeking a seasoned Project Engineer to lead large-scale capital and process improvement projects within a CFR 21 compliant environment. You will manage scopes, budgets and cross-functional teams, ensuring IQ/OQ/PQ validation of equipment and processes.

Responsibilities include change control, CAPAs, and tight cost management, while maintaining schedules and reporting to plant leadership. Prior experience with Lean/Six Sigma is preferred and exposure to QMS is required.