Mechanical Engineer

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 SolidWorks 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.

Requirements

• 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 SolidWorks 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.

Skills

• 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.
• Experience 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 detail, safety, and quality. Work takes place in regulated, GMP-compliant production areas, which may include cleanroom environments with defined gowning and hygiene protocols. The engineer works closely with production, maintenance, quality, and technical teams on the manufacturing floor, frequently interacting with automated equipment, filling systems, welding stations, and packaging lines. The environment emphasizes continuous improvement, reliability, and efficiency, supported by modern engineering tools such as SolidWorks and AutoCAD, and structured validation and risk management practices.

Pay

The pay range for this position is $43.00 - $53.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a Contract to Hire, fully onsite position based in Irvine, CA.