Manufacturing Engineer

Sharp Packaging Solutions, part of UDG Healthcare plc; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking a Manufacturing Engineer to design, optimize, and troubleshoot pharmaceutical packaging processes. You will collaborate with cross-functional teams to improve efficiency, ensure GMP compliance, and support continuous improvement in a highly regulated environment.

Responsibilities include selecting and maintaining manufacturing equipment, authoring change controls, and mentoring operators on new processes and safety procedures.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Pharmaceutical Engineering or related field; degree in progress considered.
• 3+ years in a manufacturing engineering role in pharma/life sciences.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP).
• Experience with process design, process control, and equipment validation in a regulated environment.
• Proficiency with AutoCAD, SolidWorks, or process simulation tools.
• Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.

Responsibilities

• Design, optimize, and troubleshoot manufacturing processes to improve efficiency, reduce waste, and enhance product quality.
• Evaluate, select, and oversee installation and maintenance of manufacturing equipment.
• Ensure GMP, FDA compliance and maintain regulatory documentation.
• Author Change Controls and WRKIs; Review MPRs.
• Collaborate with QA to identify corrective actions and perform root-cause analysis.
• Lead or participate in cross-functional process improvement, facility upgrades, or scale-up projects.
• Train operators and technicians on new processes, equipment, and safety procedures.

Skills

Manufacturing engineering

Lean manufacturing

Six Sigma

Education

Bachelor’s degree in Mechanical/Chemical/Pharmaceutical Engineering or related field

Tools

AutoCAD

SolidWorks

Process simulation tools

Job description

Our work truly matters and our resourcefulness can make all the difference in getting life-saving drugs to the people who need them, when they need them. We’re more efficient and effective when we’re not overly bound to a set way of working. Bring your resourcefulness and agility to continue your career at Sharp.

The Manufacturing Engineer will play a crucial role in the design, optimization, and troubleshooting of manufacturing processes to ensure efficient, safe, and high-quality production of pharmaceutical products. This position requires hands on trouble shooting of electromechanical packaging equipment. This position involves close collaboration with cross-functional teams to support process improvement, compliance with regulatory requirements, and continuous improvement in a highly regulated environment.

Key Responsibilities

• Process Optimization: Design, develop, and implement processes to improve manufacturing efficiency, reduce waste, and enhance product quality. Troubleshoot and resolve production issues to minimize downtime and ensure smooth operations.
• Equipment and Technology Management: Evaluate, select, and oversee the installation and maintenance of manufacturing equipment, ensuring they are functioning according to specifications and industry standards.
• Compliance and Documentation: Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards. Maintain accurate records, reports, and documentation in accordance with regulatory guidelines.
• Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc.
• Quality Control and Assurance: Collaborate with quality assurance teams to identify and implement corrective actions, conduct root cause analysis for quality issues, and ensure continuous product quality in the production process.
• Project Management: Lead or participate in cross-functional teams for process improvement, facility upgrades, or new product introduction projects. Provide technical guidance on new product development and scale-up processes.
• Training and Support: Train and mentor operators and technicians on new processes, equipment, and safety procedures to ensure effective and efficient production workflows.

Continuous Improvement: Identify opportunities for process automation, cost reduction, and other performance improvements. Foster a culture of continuous improvement using Lean, Six Sigma, or similar methodologies.

• Troubleshooting: Provide engineering support during production to resolve mechanical, electrical, or process-related problems in a timely manner.
• Safety and Risk Management: Promote a safe working environment by adhering to health and safety protocols and identifying any potential risks or hazards in the manufacturing processes.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field. (Degree in progress will be considered)
• 3+ years of experience in a manufacturing engineering role, preferably within the pharmaceutical or life sciences industry.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP, etc.).
• Experience with process design, process control, and equipment validation in a regulated manufacturing environment.
• Proficiency in the use of engineering software, such as AutoCAD, SolidWorks, or process simulation tools.
• Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.