Job Description

Packaging Engineer

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

Why This Role Matters

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.

What You'll Achieve

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

Packaging Process & Record Development

On average, this will represent about 35% of your time. In this aspect of your position, we will expect you to:

• 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.

Packaging Equipment Design

On average, this will represent about 30% of your time. In this aspect of your position, we will expect you to:

• 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.

Client Packaging Design, Labeling & Serialization Support

On average, this will represent about 35% of your time. In this aspect of your position, we will expect you to:

• 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.

Necessary Expertise and Skills:

• 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.

Minimum Requirements

Minimum Qualifications For The Role:

• 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.

Physical, Sensory, Cognitive & Neurological Demands:

• 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:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Dental Insurance
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long-Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

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.

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