ARx Principal Packaging Engineer

ARx; Northern (KY); Hybrid; USD 150,000 - 190,000; Full time

Job summary

ARx seeks a Principal Packaging Engineer to lead design, development, validation, and commercialization of pharmaceutical packaging systems in a cGMP environment.

You will collaborate across R&D, Quality, Operations, and Regulatory to deliver compliant, cost-efficient packaging solutions and mentor junior engineers while driving improvements.

Qualifications

• Bachelor's degree in Packaging Engineering/Packaging Science or related field.
• 10+ years of packaging engineering in pharma/regulated manufacturing.
• CPP and Lean Six Sigma are preferred.
• Experience leading complex packaging development projects.
• Familiarity with serialization technologies and FDA cGMP.

Responsibilities

• Lead design, development, qualification, and commercialization of packaging processes.
• Provide technical leadership for packaging materials, films, foils, cartons, labels, and packaging systems.
• Develop packaging specs, drawings, and documentation.
• Support equipment selection, FAT/SAT, and IQ/OQ/PQ activities.
• Conduct root cause analysis and drive corrective actions.
• Collaborate with Quality, Regulatory, and cross-functional teams for submissions and audits.
• Develop standards, SOPs, and best practices; mentor engineers.
• Drive cost reduction, sustainability, and productivity improvements.
• Perform risk assessments using FMEA and related tools.

Skills

Cross-functional leadership

Communication

Root cause analysis

Project management

Problem solving

Leadership

Continuous improvement

Education

Bachelor's degree in Packaging Engineering/Packaging Science

Alternative: mechanical/chemical engineering or materials science

Certified Packaging Professional (CPP)

Lean Six Sigma Green/Black Belt

Tools

Excel

Word

PowerPoint

Outlook

Statistical software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

ARx Principal Packaging Engineer

Full Time Operatives Glen Rock, PA, US

8 days ago Requisition ID: 1579

Job Summary:

The Principal Packaging Engineer leads the design, development, validation, and commercialization of pharmaceutical packaging systems while ensuring compliance with cGMP and 21CFR211 requirements. This role partners cross-functionally to deliver compliant, efficient, and cost-effective packaging solutions that support commercial manufacturing and continuous improvement.

Essential Functions:

• Independently lead the design, development, qualification, and commercialization of primary and secondary pharmaceutical packaging processes
• Provide technical leadership for packaging materials including films, foils, laminates, cartons, labels, pouches, and specialty delivery systems
• Develop packaging specifications, engineering drawings, and technical documentation.
• Support equipment selection, FAT, SAT, commissioning, startup of new packaging lines and IQ/OQ/PQ
• Independently troubleshoot complex packaging and manufacturing issues utilizing structured root cause analysis
• Lead supplier technical evaluations, material qualifications, and change control activities
• Collaborate with Quality and Regulatory teams to support submissions, audits, inspections, and investigations
• Adhere to cGMP work practices to ensure strict compliance with applicable GXP procedures and compliance requirements.
• Develop engineering standards, SOPs, and best practices for packaging processes
• Mentor junior engineers and provide technical leadership across multiple manufacturing lines
• Drive cost reduction, sustainability, waste reduction, and productivity improvement initiatives
• Perform risk assessments using FMEA and other quality engineering tools
• Conducts deviation investigations; develops and implements preventative actions.
• Experience with Serialization and Anti-counterfeiting technologies.
• Works in close collaboration on cross-functional teams with R&D, Quality, Operations, Marketing and Clients to accomplish successful outcomes.
• Performs a variety of engineering tasks independently, which include but are not limited to preparation of experimental and validation protocols and execution thereof in the Packaging areas in compliance with 21CFR211 Regulatory standards.
• Performs other duties and responsibilities as assigned.

Qualifications:

• Bachelor's degree in Packaging Engineering or Packaging Science is strongly preferred; alternatively, a bachelor’s degree in mechanical or chemical engineering, materials science, or a related discipline.
• 10+ years of packaging engineering experience in pharmaceutical, medical device, biotechnology, or regulated manufacturing required.
• Certified Packaging Professional (CPP) preferred.
• Lean Six Sigma Green or Black Belt preferred.
• Demonstrated experience leading complex packaging development projects
• Familiarity with serialization technologies
• Strong knowledge of FDA cGMP requirements
• Strong understanding of packaging materials and material science
• Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
• Engineering principles, concepts and methodology foundational knowledge and ability to practically apply them.
• Excel, Word, PowerPoint, Outlook, Statistical software package capability.
• Strong written and verbal communication skills, with the ability to clearly organize and convey technical information, manage multiple priorities, and collaborate effectively in a cross-functional team environment. Time flexibility to occasionally work extended hours and/or different shifts as programs and business demands. Must be able to travel as needed to support the business (<25%).
• Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc.