Packaging Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

3d•$93,198 - $128,613•Onsite

About The Position

The mission of the Packaging Engineer is to ensure that client products are packaged, labeled, and serialized reliably, compliantly, and efficiently across the full range of primary and secondary packaging formats our CDMO supports. This role bridges packaging process design, equipment engineering, and client technical requirements, translating a client's packaging design into a robust, validated, and repeatable production process. The position requires strong technical packaging engineering skills, hands-on experience with packaging equipment, and the ability to work closely with clients, Quality, and Development, and Manufacturing to bring new packaging configurations into commercial production. The Packaging Engineer supports ProMed’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

Requirements

Strong technical knowledge of primary and secondary packaging processes, equipment, and materials used in pharmaceutical packaging.
Experience authoring and executing packaging process validation protocols and batch packaging records.
Hands-on experience with packaging equipment design, qualification, and troubleshooting.
Working knowledge of serialization and labeling regulations, including DSCSA and EU FMD requirements.
Ability to manage multiple client projects and packaging technical requirements simultaneously.
Strong communication and project management skills for client-facing and cross-functional collaboration.
Bachelor's degree in Packaging Engineering, Mechanical Engineering, or related technical discipline.
3+ years of experience in pharmaceutical or CDMO packaging engineering, process development, or equipment engineering.
Demonstrated experience with packaging equipment qualification and process validation.
Familiarity with serialization, labeling, and track-and-trace regulatory requirements.
Working knowledge of cGMP requirements as they apply to packaging operations.

Responsibilities

Develop and author packaging process instructions, batch packaging records, and line clearance procedures for new and existing client programs.
Define and document critical process parameters for packaging operations, including line speeds, torque/seal settings, and in-process checks.
Author and execute packaging process validation protocols and reports, ensuring processes are robust and reproducible at commercial scale.
Support root cause investigations for packaging-related deviations and implement corrective and preventive actions (CAPAs).
Continuously improve packaging processes and records to reduce waste, downtime, and human error.
Design, specify, and evaluate packaging equipment and tooling (e.g., assembly and fill lines, printing, cartoners, labelers, case packers) to meet client and site requirements.
Lead or support equipment installation, commissioning, and qualification (IQ/OQ/PQ) activities for new or modified packaging lines.
Collaborate with Maintenance and Engineering to troubleshoot equipment performance issues and implement design improvements.
Evaluate and integrate change parts, format parts, and tooling needed to support new packaging configurations.
Assess equipment capacity and constraints to support capital planning and production scheduling.
Partner with clients to translate their packaging design requirements, artwork, and labeling specifications into manufacturable packaging processes.
Develop packaging component specifications, artwork proofs, and labeling content for compliance with regulatory and client requirements.
Support implementation of serialization and aggregation requirements, coordinating with IT, Quality, and equipment vendors to ensure compliance with DSCSA, EU FMD, and other applicable regulations.
Lead packaging design reviews and technical discussions with clients during new product introduction and technology transfer.
Support label reconciliation and traceability requirements to ensure accurate and compliant product labeling.