Packaging Process Engineer II - Pharma Manufacturing & CI

RXinsider LTD.; Petersburg (VA); On-site; USD 100,000 - 130,000; Full time

Job summary

Civica in Petersburg, Virginia seeks a Packaging Process Engineer II to join its first fill-finish facility for essential generic sterile medicines. You will lead pen assembly and packaging equipment programs, supervise line serialization, and coordinate vendor activities from design through qualification and start-up.

You will interface with Manufacturing, Quality, and Supply Chain, drive process improvements using DMAIC and FMEA, and support regulatory inspections.

Qualifications

• Exposure to pharmaceutical manufacturing and operations preferred.
• Strong interpersonal and communication skills, both written and verbal.
• Ability to adapt and adjust priorities.
• Project management experience.
• Ability to work effectively with outside suppliers.
• Knowledge of Lean/Six Sigma methodologies.
• Strong problem-solving skills.
• Hands-on mechanical aptitude and willingness to own new technical challenges.
• Familiarity with engineering drawings is advantageous.

Responsibilities

• Lead and manage equipment vendors including FAT/SAT and on-site maintenance.
• Complete FAT, SAT, Commissioning and engineering studies.
• Support IQ/OQ/PQ validation activities.
• Prepare cGMP documentation for production operations.
• Coordinate technical deliverables across functions to support processes and launches.
• Drive continuous improvement using DMAIC and FMEA.
• Adapt priorities in response to disruptions to operations.
• Manage equipment changes per site change control procedures.
• Participate in regulatory inspections (FDA/DEA).
• Improve equipment reliability to support scale-up and ramp-up.

Skills

Project management

Lean Six Sigma

Data-driven analysis

Supplier management

Communication skills

Mechanical aptitude

cGMP experience

Documentation & reporting

Education

B.S. in Engineering or Science

Job description

Civica in Petersburg, Virginia seeks a Packaging Process Engineer II to join its first fill-finish facility for essential generic sterile medicines. You will lead pen assembly and packaging equipment programs, supervise line serialization, and coordinate vendor activities from design through qualification and start-up.

You will interface with Manufacturing, Quality, and Supply Chain, drive process improvements using DMAIC and FMEA, and support regulatory inspections.