Packaging Process Engineer II: CI & Validation Lead

BioSpace; Petersburg (VA); On-site; USD 100,000 - 140,000; Full time

Job summary

Civica is seeking a Packaging Process Engineer II in Petersburg, VA to help create pen assembly and packaging operations at our first fill-finish facility for essential sterile injectables. You will coordinate vendor activities, support validation, and drive continuous improvement across manufacturing, quality, and supply chain teams.

Ideal candidates have 5+ years in a relevant engineering field, a B.S. degree, and experience with Lean Six Sigma methodologies.

Qualifications

• 5+ years of experience in the discipline.
• B.S. in Engineering or Science required.
• Experience in a cGMP environment preferred.
• Ability to manage teams on the manufacturing floor.
• Data-driven root cause analysis using Six Sigma, 5-Why, or fishbone diagrams.
• Adaptable to changing priorities and project demands.
• CQV experience and greenfield facility start-up experience preferred.
• Ability to explain complex issues to external customers/agencies.

Responsibilities

• Management of equipment vendors including FAT & SAT, on-site maintenance visits, and spare parts assessments.
• Complete FAT, SAT, commissioning and engineering studies.
• Support validation activities such as IQ, OQ, and PQ.
• Prepare cGMP documentation to support production operations.
• Coordinate technical deliverables across functions to support processes and launches.
• Lead cross-functional teams to troubleshoot, drive CI/TPM, and optimize processes.
• Adapt priorities in response to disruptions and changes in operations.
• Participate in regulatory inspections (FDA/DEA).
• Drive equipment reliability during transition from project to ongoing manufacturing ramp-up.

Skills

Interpersonal skills

Communication

Project management

External suppliers

Lean Six Sigma

Problem solving

Mechanical aptitude

Engineering drawings

Team management

Education

B.S. in Engineering or Science

Job description

Civica is seeking a Packaging Process Engineer II in Petersburg, VA to help create pen assembly and packaging operations at our first fill-finish facility for essential sterile injectables. You will coordinate vendor activities, support validation, and drive continuous improvement across manufacturing, quality, and supply chain teams.

Ideal candidates have 5+ years in a relevant engineering field, a B.S. degree, and experience with Lean Six Sigma methodologies.