Mechanical Engineer

Job Title:

Mechanical Engineer - Pharmaceutical Manufacturing

Job Description

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…