Packaging Process Engineer II – Lean & CI Focus

BioSpace; Petersburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Packaging Process Engineer II at Civica will play a key role in establishing pen assembly and packaging operations at Civica’s first fill-finish facility in Petersburg, Virginia. You will coordinate equipment vendors, manage FAT/SAT, assist commissioning, and support IQ/OQ/PQ validation to ensure compliant, efficient production lines.

You will collaborate across Manufacturing, Quality, and Supply Chain, lead continuous improvement initiatives using DMAIC and FMEA, and drive reliable,

Qualifications

• 5+ years of experience in pharmaceutical manufacturing or packaging operations.
• Experience with cGMP environments.
• Ability to manage cross-functional teams on the floor.

Responsibilities

• Manage equipment vendors through FAT/SAT, maintenance visits, and CI projects.
• Complete FAT, SAT, commissioning, and engineering studies.
• Support IQ/OQ/PQ validation activities.
• Prepare cGMP documentation to support production.
• Coordinate technical deliverables across functions for launches.
• Lead cross-functional teams to troubleshoot and drive process improvement with DMAIC and FMEA.
• Adapt priorities in response to disruptions.
• Lead change control for equipment.
• Participate in regulatory inspections (FDA/DEA).
• Improve equipment reliability to support ramp-up production.

Skills

Project management

Lean Six Sigma

DMAIC

FMEA

Problem solving

Mechanical aptitude

Communication skills

Education

B.S. in Engineering or Science

Job description

The Packaging Process Engineer II at Civica will play a key role in establishing pen assembly and packaging operations at Civica’s first fill-finish facility in Petersburg, Virginia. You will coordinate equipment vendors, manage FAT/SAT, assist commissioning, and support IQ/OQ/PQ validation to ensure compliant, efficient production lines.

You will collaborate across Manufacturing, Quality, and Supply Chain, lead continuous improvement initiatives using DMAIC and FMEA, and drive reliable,