Packaging Process Engineer II (Pharmaceutical Manufacturing)

Location: Onsite at hirify.global's fill-finish manufacturing facility in Petersburg, Virginia, United States

Company

hirify.global manufactures and supplies essential generic sterile injectable medicines with a mission to make affordable, quality medicines accessible to all.

What you will do

• Manage equipment vendors through design, fabrication, installation, qualification, and ongoing maintenance.
• Lead FAT, SAT, commissioning, engineering studies, and support IQ, OQ, and PQ validation activities.
• Provide front-line technical support for pen assembly, packaging equipment, and line-level serialization systems.
• Prepare cGMP documentation and coordinate technical deliverables across Manufacturing, Quality, Supply Chain, suppliers, and other functions.
• Lead cross-functional troubleshooting, change control, continuous improvement, and process optimization using DMAIC and FMEA.
• Improve equipment reliability through continuous improvement and TPM activities during manufacturing ramp-up.

Requirements

• Bachelor's degree in Engineering or a Science discipline.
• 5+ years of experience in the relevant engineering discipline.
• Experience with project management, supplier coordination, root-cause analysis, and data-driven continuous improvement.
• Knowledge of Lean/Six Sigma methodologies and strong mechanical aptitude with a hands-on approach.
• Ability to manage teams on the manufacturing floor, explain complex technical issues, and adapt to changing priorities.
• Ability to work in an onsite pharmaceutical manufacturing environment and occasionally lift or move up to 25 pounds.

Nice to have

• Experience with pharmaceutical manufacturing, pen assembly, packaging equipment, and serialization systems.
• Experience in a cGMP environment, CQV, or greenfield facility start-up.
• Familiarity with engineering and architectural/construction drawings.

Culture & Benefits

• Work supports the manufacture and supply of affordable generic sterile injectable medicines.
• Regular collaboration with Manufacturing, Quality, Supply Chain, external suppliers, and regulatory agencies.
• Participation in FDA and DEA regulatory inspections.