Packaging Process Engineer II - GMP, CI & Validation

Civica; Petersburg (VA); On-site; USD 110,000 - 140,000; Full time

Job summary

Civica is seeking a Packaging Process Engineer II to join its first fill-finish facility in Petersburg, VA. You will oversee pen assembly and packaging equipment, lead vendor activities, and support validation and regulatory readiness.

This role interfaces with Manufacturing, Quality, and Supply Chain to ensure scalable, compliant processes. You will drive continuous improvement using DMAIC and FMEA, manage changes, and collaborate across teams to launch reliable packaging lines while

Qualifications

• Experience in pharmaceutical manufacturing environments preferred.
• Ability to manage vendor relationships and multi-project initiatives.
• Knowledge of Lean/Six Sigma methodologies and continuous improvement.
• Familiarity with cGMP documentation and regulatory inspections.

Responsibilities

• Manage equipment vendors including FAT & SAT, on-site maintenance, and CI projects.
• Complete FAT, SAT, Commissioning and Engineering Studies.
• Support IQ/OQ/PQ validation activities.
• Prepare cGMP documentation to support production.
• Coordinate deliverables across functions for new processes and launches.
• Lead cross-functional teams to troubleshoot, apply DMAIC and FMEA for improvements.
• Adapt priorities in response to disruptions in operations.
• Assist in site change control procedures for equipment.

Skills

Pharmaceutical manufacturing

Project management

Lean/Six Sigma

DMAIC & FMEA

Cross-functional collaboration

Mechanical aptitude

Regulatory knowledge (FDA, DEA)

Education

B.S. in Engineering or Science

Tools

FAT/SAT

IQ/OQ/PQ

Job description

Civica is seeking a Packaging Process Engineer II to join its first fill-finish facility in Petersburg, VA. You will oversee pen assembly and packaging equipment, lead vendor activities, and support validation and regulatory readiness.

This role interfaces with Manufacturing, Quality, and Supply Chain to ensure scalable, compliant processes. You will drive continuous improvement using DMAIC and FMEA, manage changes, and collaborate across teams to launch reliable packaging lines while