ARx Principal Packaging Engineer

Adhesives Research Inc.•Glen Rock, PA

21d•Onsite

About The Position

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.

Requirements

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.
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%).

Nice To Haves

Certified Packaging Professional (CPP) preferred.
Lean Six Sigma Green or Black Belt preferred.

Responsibilities

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.