Equipment Packaging Engineer

Job Summary:

The Equipment Packaging Engineer is responsible for specifying, designing, implementing, and optimizing packaging machinery and automated packaging lines used in the production of pharmaceutical and consumer health products. This role focuses on equipment performance, reliability, integration, validation, and continuous improvement to ensure operational efficiency, product quality, and compliance with cGMP and regulatory standards.

Duties and Responsibilities:

Equipment & Line Design

• Lead the design, specification, and procurement of packaging equipment including blister machines, bottle lines, cartoners, labelers, pouching systems, serialization stations, and case packing equipment.
• Develop URS, equipment specifications, functional requirements, and design documentation for new or upgraded machinery.
• Evaluate equipment designs for manufacturability, reliability, and integration with existing systems, utilities, and facility layouts.

Equipment Installation, Commissioning & Qualification

• Manage equipment installation, FAT/SAT, commissioning, and validation activities (IQ/OQ/PQ).
• Coordinate with vendors, system integrators, and internal maintenance teams to ensure equipment is installed and qualified per project requirements.
• Troubleshoot mechanical, electrical, and control-system issues during startup and post-launch phases.

Line Optimization & Performance Improvement

• Analyze packaging line performance to identify productivity constraints, material handling challenges, and automation improvement opportunities.
• Implement upgrades that improve throughput, reduce downtime, enhance quality, and support continuous improvement goals.
• Perform root-cause analysis on recurring equipment issues and develop sustainable corrective actions.

Technical Documentation & Compliance

• Develop and maintain technical documentation including equipment validations, specifications, drawings, change controls, SOPs, and preventive maintenance plans.
• Ensure compliance with cGMP, FDA/EMA regulations, internal quality systems, and safety standards.
• Support internal audits, regulatory inspections, and technical reviews related to equipment and packaging operations.

Cross-Functional Collaboration

• Work closely with Operations, Maintenance, Quality, Engineering, EHS, and Supply Chain teams to ensure equipment readiness and operational alignment.
• Partner with suppliers, OEMs, and contractors to resolve equipment-related issues and evaluate new technologies.
• Provide technical training to operators, technicians, and maintenance staff.

Required Skills/Abilities:

• Experience with serialization systems (track-and-trace, vision systems, coding/printing technologies).
• Familiarity with PLCs, HMIs, robotics, sensors, and line controls.
• Lean Manufacturing or Six Sigma certification.
• Experience leading equipment start-ups and managing vendor relationships.
• Knowledge of materials handling, conveyors, and automated packaging technologies.

Education and Experience:

• Bachelor’s degree in Mechanical Engineering, Packaging Engineering, Electrical Engineering, Mechatronics, or related field.
• 5-10 years of experience working with packaging equipment in the pharmaceutical, biotech, food, beverage, or consumer products industry.
• Strong knowledge of packaging equipment design, automation, mechanical systems, controls, and integration.
• Experience with FAT/SAT, commissioning, and qualification (IQ/OQ/PQ).
• Understanding of cGMP, FDA/regulated environments, and packaging line compliance requirements.
• Proficiency with CAD tools and equipment layout design.
• Strong problem-solving, project management, and cross-functional communication skills.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products-including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances-is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled