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 (
- 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.
