Packaging Process Engineer II: Lead GMP Fill-Finish Ops

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

Job summary

Civica Rx in Petersburg, Virginia is seeking a Packaging Process Engineer II to help build pen assembly and packaging operations at its first fill-finish facility for essential generic sterile injectables.

The role coordinates vendor activities, supports validation, and ensures cGMP compliance on the manufacturing floor while interfacing with Manufacturing, Quality, and Supply Chain teams to enable successful production launches.

Qualifications

• 5+ years of experience in the discipline is required.
• B.S. in Engineering or Science discipline required.
• Experience in a cGMP environment preferred.
• Ability to manage teams to execute activities on the manufacturing floor.
• Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram).
• Ability to adapt to changing priorities as project demands and business needs change.
• CQV experience and greenfield facility start-up experience preferred.
• Ability to explain complex technical issues to external customers/agencies.
• Demonstrated excellence in planning and organizational skills.

Responsibilities

• Coordinate equipment vendor activities including FAT & SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.
• Complete FAT, SAT, Commissioning and Engineering Studies.
• Support Validation activities such as IQ, OQ, and PQ.
• Prepare the required cGMP documentation to support production operations.
• Coordinate technical deliverables across all business functions to support successful processes and product launches.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Ability to quickly adapt and adjust priorities in response to unforeseen disruptions in operations.
• Manage changes for responsible equipment as per site change control procedures.
• Participate in regulatory inspections (e.g. FDA, DEA audits).
• Lead improvement of equipment reliability through CI and TPM processes to support the transition from project level to sustainable manufacturing/ramp up production.

Skills

Project management

Lean Six Sigma

Problem solving

Communication skills

Prioritization

External supplier liaison

Mechanical aptitude

Technical ownership

Engineering drawings

Education

B.S. in Engineering or Science

Job description

Civica Rx in Petersburg, Virginia is seeking a Packaging Process Engineer II to help build pen assembly and packaging operations at its first fill-finish facility for essential generic sterile injectables.

The role coordinates vendor activities, supports validation, and ensures cGMP compliance on the manufacturing floor while interfacing with Manufacturing, Quality, and Supply Chain teams to enable successful production launches.