Packaging Engineer

Actalent; Tennessee; On-site; USD 70,000 - 110,000; Full time

Job summary

Actalent is seeking a Packaging Engineer to design, implement, and optimize pharmaceutical packaging systems within a cGMP environment. You will manage packaging specifications, lead change controls, and support product launches while ensuring GMP compliance.

You will collaborate with operations, quality, engineering, and clients, troubleshooting line issues and driving continuous improvements in packaging processes and equipment.

Qualifications

• Minimum 1 year in a pharmaceutical cGMP environment.
• At least 2 years in pharma packaging operations or engineering.
• Bachelor’s degree in Mechanical, Chemical, or Industrial Engineering.
• Experience with packaging systems and related equipment.
• Experience with change management and change controls.

Responsibilities

• Design, develop, and maintain pharmaceutical packaging systems and specifications to support existing and new products.
• Lead packaging-related changes, including change controls and documentation throughout the process.
• Drive packaging projects and product launches from planning through implementation, ensuring timelines and quality.
• Troubleshoot packaging and equipment issues on packaging lines and implement corrective actions.
• Collaborate with operations to improve packaging line performance, efficiency, and reliability.
• Translate customer and stakeholder requirements into compliant packaging solutions.
• Support serialization initiatives and GMP/FDA regulatory compliance.
• Train staff on packaging processes and best practices.
• Coordinate with cross-functional teams to resolve issues and implement improvements.
• Develop and maintain packaging specifications for labels, cartons, bottles, and pallets.

Skills

pharmaceutical cGMP experience

GMP compliance & documentation

packaging systems experience

project management

change management

cross-functional collaboration

troubleshooting packaging lines

Education

Bachelor’s degree in Engineering (Mechanical/Chemical/Industrial)

Tools

ERP systems

MES systems

Job description

Job Description

Job Title: Packaging Engineer

Job Description

This Packaging Engineer role focuses on designing, implementing, and optimizing pharmaceutical packaging systems within a cGMP manufacturing environment. The position manages packaging specifications, supports packaging-related projects and product launches, leads change controls, troubleshoots packaging issues, and serves as a key technical resource for packaging operations while ensuring compliance with GMP requirements.

Responsibilities

• Design, develop, and maintain pharmaceutical packaging systems and specifications to support existing and new products.
• Manage packaging-related changes, including leading change controls and coordinating documentation throughout the change management process.
• Lead and support packaging projects and product launches from planning through implementation, ensuring timelines and quality standards are met.
• Troubleshoot packaging and equipment issues on the packaging lines, identifying root causes and implementing effective corrective actions.
• Work closely with operations to improve packaging line performance, efficiency, and reliability.
• Translate customer and internal stakeholder requirements into practical, compliant packaging solutions.
• Support serialization initiatives and ensure packaging operations align with GMP and other regulatory compliance requirements.
• Train employees on packaging processes, procedures, and best practices to promote consistent and compliant operations.
• Collaborate with cross-functional teams including operations, quality, engineering, and clients to resolve issues and implement improvements.
• Develop and maintain packaging specifications, including labels, cartons, bottles, and pallet configurations where applicable.
• Support continuous improvement activities related to packaging processes, equipment, and documentation.
• Contribute to validation and qualification activities for packaging equipment and processes as needed.

Essential Skills

• Minimum 1 year of experience working in a pharmaceutical cGMP environment.
• Experience working in regulated manufacturing with a strong understanding of GMP compliance and documentation requirements.
• At least 2 years of experience in the pharmaceutical industry supporting packaging operations, manufacturing, or engineering activities.
• Bachelor’s degree in Engineering, preferably in Mechanical, Chemical, or Industrial Engineering.
• Understanding of manufacturing processes and equipment, particularly within pharmaceutical packaging or production environments.
• Hands-on experience with packaging systems, production processes, or manufacturing operations.
• Ability to troubleshoot technical and process issues related to packaging lines and equipment.
• Project management experience managing projects from planning through implementation.
• Experience with change management, including documentation and coordination of change controls.
• Ability to coordinate and communicate effectively with multiple stakeholders across operations, quality, engineering, and client teams.
• Demonstrated experience in packaging within a manufacturing environment.
• Pharmaceutical packaging experience in GMP or FDA-regulated facilities.

Additional Skills & Qualifications

• Pharmaceutical packaging experience with exposure to various packaging formats and configurations.
• Experience with serialization in pharmaceutical packaging operations.
• Experience developing and maintaining packaging specifications, including labels, cartons, bottles, and pallet configurations.
• Previous involvement in change control processes within a regulated environment.
• Validation experience related to packaging equipment or processes.
• Continuous improvement experience, including identifying and implementing process improvements on packaging lines.
• Exposure to ERP and/or MES systems used in manufacturing and packaging operations.
• Experience in packaging engineering, packaging design, or packaging line support.
• Experience in medical device or mechanical packaging environments is beneficial.
• Strong communication and training skills to effectively guide and support operations staff.
• Interest in professional growth and development within engineering-focused career paths.

Work Environment

The role operates within a pharmaceutical manufacturing and packaging environment that adheres to cGMP and FDA regulatory requirements. The Packaging Engineer works on and around packaging lines, production equipment, and related systems, supporting day-to-day op