Packaging Process Engineer II — CI & Start-Up

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

Job summary

Civica Rx is seeking a Packaging Process Engineer II to lead packaging operations at its Virginia facility. The role interfaces with Manufacturing, Quality, and Supply Chain to ensure compliant, efficient packaging lines and serialization systems.

The candidate will manage vendor activities, validation, and continuous improvement initiatives, requiring strong problem-solving skills and hands-on mechanical aptitude in a CGMP setting.

Qualifications

• 5+ years of experience in packaging/engineering roles within pharma or CGMP environments.
• B.S. in Engineering or Science discipline.
• Experience with cGMP environments preferred.
• CQV experience and greenfield startup exposure preferred.

Responsibilities

• Coordinate equipment vendor activities including FAT/SAT, installation, IQ/OQ/PQ, and commissioning.
• Support validation activities such as IQ, OQ, PQ and cGMP documentation.
• Prepare and maintain regulatory and batch documentation for production operations.
• Coordinate deliverables across Manufacturing, Quality and Supply Chain to support launches.
• Lead cross-functional teams to troubleshoot, drive CI/ TPM initiatives and process improvements (DMAIC, FMEA).
• Adapt priorities quickly in response to disruptions; manage changes under site change control.
• Support regulatory inspections (FDA/DEA audits) as needed.
• Improve equipment reliability and transition projects to sustainable manufacturing.

Skills

Lean Six Sigma

DMAIC

FMEA

Problem solving

Mechanical aptitude

Communication skills

Cross-functional teamwork

cGMP knowledge

Regulatory inspections

Engineering drawings

Ownership of new technical challenges

Education

B.S. in Engineering

Tools

No specific tools listed

Job description

Civica Rx is seeking a Packaging Process Engineer II to lead packaging operations at its Virginia facility. The role interfaces with Manufacturing, Quality, and Supply Chain to ensure compliant, efficient packaging lines and serialization systems.

The candidate will manage vendor activities, validation, and continuous improvement initiatives, requiring strong problem-solving skills and hands-on mechanical aptitude in a CGMP setting.