Mechanical Engineer

Mechanical Engineer – Pharmaceutical Manufacturing

This role supports high-volume pharmaceutical manufacturing operations focused on IV bag production. The Mechanical Engineer provides hands-on support for automated manufacturing equipment, tooling, filling systems, welding operations, and packaging processes, while driving equipment reliability, quality improvements, and process optimization in a GMP-regulated environment.

Responsibilities

• Support IV bag manufacturing processes, including welding, filling, printing, labeling, and automated packaging systems.
• Lead equipment troubleshooting activities to quickly resolve mechanical, automation, and process issues impacting production.
• Conduct root cause investigations for quality issues, downtime events, and production inefficiencies, and document findings in a structured manner.
• Support CAPA investigations and implement effective corrective and preventive actions to prevent recurrence of issues.
• Design and implement equipment modifications, mechanical improvements, and new tooling solutions using Solid Works and AutoCAD.
• Improve equipment performance, reliability, and overall equipment effectiveness (OEE) to increase throughput and reduce scrap.
• Support validation and equipment qualification activities, including IQ, OQ, and PQ, in accordance with quality and regulatory requirements.
• Participate in change control processes for equipment and process changes, ensuring compliance with internal procedures and GMP standards.
• Analyze process and equipment performance data to identify trends, risks, and opportunities for continuous improvement.
• Collaborate closely with Quality, Operations, Maintenance, and Technical Services teams to resolve issues and deliver robust manufacturing solutions.
• Ensure all engineering activities align with GMP requirements, company quality systems, and applicable regulatory standards.
• Contribute to preventive maintenance strategies and reliability engineering efforts to minimize unplanned downtime.
• Apply risk assessment tools such as FMEA to evaluate process and equipment changes and propose risk mitigation actions.
• Support automation and machine design initiatives to enhance manufacturing capabilities and support new or improved products.
• Provide technical support for filling equipment, packaging equipment, and cleanroom manufacturing operations.

Essential Skills

• Bachelor's Degree in Mechanical Engineering or a closely related discipline.
• 3+ years of pharmaceutical manufacturing experience OR 5+ years of manufacturing engineering experience in a regulated industry.
• 2+ years of hands-on experience troubleshooting manufacturing equipment in a production environment.
• Proficiency with Solid Works for mechanical design, modeling, and tooling development.
• Experience using AutoCAD for equipment layouts, drawings, and design updates.
• Demonstrated experience supporting root cause investigations and CAPA activities.
• Strong understanding of mechanical systems, including pneumatics, heat transfer, tooling, and high-volume manufacturing processes.
• Experience working within GMP-regulated manufacturing environments, such as medical device or pharmaceutical facilities.
• Experience with equipment qualification and validation activities, including IQ, OQ, and PQ.
• Proven ability to analyze equipment and process performance data to drive continuous improvement.
• Familiarity with risk assessment methodologies such as FMEA and related tools.
• Experience with preventive maintenance and reliability engineering concepts in a production setting.

Additional Skills & Qualifications

• Experience in IV bag manufacturing or similar fluid packaging operations.
• Plastics manufacturing experience, particularly in forming and sealing applications.
• Hands-on experience with thermal welding or RF welding processes for flexible packaging or plastic components.
• Cleanroom manufacturing environment experience, ideally in medical device or pharmaceutical production.
• Direct experience with filling equipment used in liquid or sterile manufacturing processes.
• Experience with automated packaging equipment in a high-volume production setting.
• in automation and machine design to support new equipment or upgrades.
• Lean Manufacturing and Continuous Improvement experience, including implementation of process improvements on the shop floor.
• Experience performing formal risk assessments and contributing to FMEA activities.
• Exposure to reliability engineering practices to enhance equipment uptime and performance.
• Strong mechanical design skills with the ability to develop and refine tooling and fixtures for production.
• Ability to work effectively in cross-functional teams, including Quality, Operations, Maintenance, and Technical Services.

Work Environment

The role is based in a high-volume pharmaceutical and medical device manufacturing environment focused on IV bag production. The facility operates multiple fully automated manufacturing lines capable of producing a very high number of units per minute, requiring strong attention to…