Senior Packaging Engineer

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

Pharmaceutical Packaging Engineer - $130-$150K++

Travel: Less than 25%

I’m recruiting for a Principal Packaging Engineer to lead the design, development, validation, and commercialization of packaging systems for an established pharmaceutical manufacturing organization in the York, PA area.

This is a senior-level individual contributor role with technical leadership responsibilities across packaging development, validation, manufacturing support, supplier qualification, and continuous improvement.

What You’ll Do

• 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

What They’re Looking For

• Bachelor’s degree in Packaging Engineering or Packaging Science strongly preferred; Mechanical Engineering, Chemical Engineering, Materials Science, or related discipline considered
• 10+ years of packaging engineering experience in pharmaceutical, medical device, biotechnology, or regulated manufacturingStrong knowledge of FDA cGMP requirements and 21 CFR Part 211
• Demonstrated experience leading complex packaging development projects
• Strong understanding of packaging materials and material science
• Experience with serialization technologies
• Experience supporting packaging validation and qualification activities
• CPP certification preferred
• Lean Six Sigma Green Belt or Black Belt preferred
• Ability to travel less than 25%
• Flexibility to occasionally support extended hours or alternate shifts based on program and business needs

This is a strong opportunity for an experienced packaging engineer who wants ownership of complex packaging programs while remaining close to the technical work.