Senior Pharmaceutical Packaging Engineer - Lead Development

Colonial Staffing Group Inc.; Pennsylvania; On-site; USD 130,000 - 150,000; Full time

Job summary

Colonial Staffing Group Inc. is recruiting a Principal Packaging Engineer for an established pharmaceutical manufacturer in the York, PA area. This senior IC role leads packaging development, validation, and commercialization, with responsibility across materials, equipment, and quality systems.

You will mentor teams, drive cost reduction and sustainability, and partner with Quality and Regulatory on submissions, audits, and investigations. Travel <25%.

Qualifications

• 10+ years of packaging engineering experience in regulated manufacturing.
• Strong knowledge of FDA cGMP requirements and 21 CFR Part 211.
• Experience leading complex packaging development projects.
• Knowledge of packaging materials and material science.
• Experience with serialization technologies.
• CPP certification or Lean Six Sigma preferred.
• Willingness to travel <25%.

Responsibilities

• Lead design, development, qualification, and commercialization of primary and secondary pharmaceutical packaging
• Provide technical leadership for films, foils, laminates, cartons, labels, pouches, and specialty delivery systems
• Develop packaging specifications, engineering drawings, and technical documentation
• Support packaging equipment selection, FAT, SAT, commissioning, startup, and IQ/OQ/PQ
• Troubleshoot complex packaging and manufacturing issues using structured root cause analysis
• Lead supplier technical evaluations, material qualifications, and change controls
• Partner with Quality and Regulatory on submissions, audits, inspections, investigations, and compliance activities
• Develop packaging engineering standards, SOPs, and best practices
• Lead risk assessments using FMEA and other quality engineering tools
• Conduct deviation investigations and develop preventative actions
• Support serialization and anti-counterfeiting technologies
• Drive cost reduction, sustainability, waste reduction, and productivity initiatives
• Prepare and execute experimental and validation protocols in compliance with 21 CFR Part 211
• Provide technical leadership and mentorship across multiple manufacturing lines

Skills

Packaging engineering

Leadership

FDA cGMP

Root cause analysis

Serialization

Quality systems

Cost reduction

Education

Bachelor's in Packaging Engineering or related

Job description

Colonial Staffing Group Inc. is recruiting a Principal Packaging Engineer for an established pharmaceutical manufacturer in the York, PA area. This senior IC role leads packaging development, validation, and commercialization, with responsibility across materials, equipment, and quality systems.

You will mentor teams, drive cost reduction and sustainability, and partner with Quality and Regulatory on submissions, audits, and investigations. Travel <25%.