Packaging Process Engineer II

Kelly Science & Clinical is seeking two Packaging Process Engineer IIs for an opportunity with one of premier clients in Petersburg, Virginia. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career.

$120,000-$135,000 base salary, plus a 10% bonus. Relocation assistance: $10,000, plus 30 days of temporary travel expenses.

This company is a generic pharmaceutical company dedicated to providing affordable, quality medicines that are accessible to all. Its first fill-finish manufacturing facility in Petersburg, Virginia, is dedicated to the manufacture and supply of essential generic sterile injectable medications.

As the Packaging Process Engineer II, you’ll work closely with Manufacturing, Quality, Supply Chain, equipment vendors, and other internal teams to create pen assembly and packaging operations. You’ll support equipment delivery from design through installation, qualification, and production ramp-up - helping establish reliable manufacturing processes for essential medicines.

• Manage equipment vendors through design, fabrication, installation, and qualification; coordinate factory and site acceptance testing (FAT/SAT), on-site maintenance, continuous improvement projects, and spare-parts criticality assessments.
• Execute FAT, SAT, commissioning, and engineering studies; support equipment validation activities, including IQ, OQ, and PQ.
• Prepare required cGMP documentation and manage changes for assigned equipment in accordance with site change-control procedures.
• Coordinate technical deliverables across business functions to support successful processes and product launches.
• Lead and participate in cross-functional teams to troubleshoot technical issues and drive continuous improvement and process optimization using methods such as DMAIC and FMEA.
• Adapt priorities quickly in response to operational disruptions and changing project or business needs.
• Participate in regulatory inspections, including FDA and DEA audits.
• Improve equipment reliability through continuous improvement and TPM processes, supporting the transition from project execution to sustainable manufacturing and production ramp-up.
• Provide front-line technical support to Manufacturing for pen assembly, packaging equipment, and line-level serialization systems.

• Bachelor’s degree in Engineering or a Science discipline required; at least 5 years of experience in the discipline required.
• Exposure to pharmaceutical manufacturing and operations is preferred, particularly pen assembly, packaging equipment, and line-level serialization systems; cGMP experience is preferred.
• Project management experience and the ability to manage teams executing work on the manufacturing floor.
• Strong written and verbal communication, interpersonal, organizational, and planning skills; able to explain complex technical issues to external customers and agencies.
• Effective working with outside suppliers; strong mechanical aptitude and a hands-on approach.
• Knowledge of Lean/Six Sigma and data-driven root-cause analysis and prioritization, including tools such as 5-Why and fishbone diagrams.
• CQV and greenfield facility start-up experience preferred; familiarity with engineering and architectural/construction drawings is highly advantageous.
• Strong problem-solving skills and the ability to adapt to changing priorities, take ownership of new technical challenges, and deliver assigned projects.
• Passion for the company’s mission to provide affordable, quality generic medicines that are accessible to all.

As part of our promise to talent, Kelly supports those who work with us through a variety of…