Packaging Engineer

• 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.

• 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.

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.
• Manual dexterity for handling components and equipment 
• Wearing PPE as required in production areas
• Visual acuity for reviewing documents, drawings, and labeling 
• Hearing sufficient for floor communication and identifying equipment issues 
• Attention to detail in visual and tactile inspection tasks
• Strong analytical and problem-solving skills 
• Ability to interpret technical and regulatory documentation 
• Capacity to manage multiple projects and priorities simultaneously 
• Sound judgment and decision-making under deadlines
• Sustained focus for detailed technical work 
• Adaptability to shifting priorities and tasks 

ProMed offers a generous benefits package including:

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.