Mechanical Engineer – GMP Equipment & Process Optimization

Actalent; Irvine (CA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Critical Illness

Accident

Hospital

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent in Irvine, CA is seeking a Mechanical Engineer to support high-volume IV bag manufacturing by troubleshooting automated equipment and optimizing production processes.

You will design equipment modifications using SolidWorks and AutoCAD, and ensure strict GMP compliance, QA documentation, and quality control.

Candidates should have a Bachelor's in Mechanical Engineering, 3+ years pharma or 5+ years regulated manufacturing, and hands-on experience with equipment validation.

Qualifications

• Bachelor's degree in Mechanical Engineering.
• 3+ years pharma OR 5+ years regulated manufacturing experience.
• Proficient in SolidWorks and AutoCAD.
• Strong background in equipment validation and root cause investigations.

Responsibilities

• Troubleshoot automated equipment in high-volume IV bag manufacturing.
• Optimize production processes for efficiency and yield.
• Design equipment modifications using SolidWorks and AutoCAD.
• Ensure compliance with GMP standards and quality documentation.

Skills

Root Cause Analysis

CAPA

FMEA

Pneumatics

Thermal Welding

RF Welding

Lean Manufacturing

Reliability Engineering

Cleanroom Operations

Mechanical Design

Process Optimization

GMP

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Job description

Actalent in Irvine, CA is seeking a Mechanical Engineer to support high-volume IV bag manufacturing by troubleshooting automated equipment and optimizing production processes.

You will design equipment modifications using SolidWorks and AutoCAD, and ensure strict GMP compliance, QA documentation, and quality control.

Candidates should have a Bachelor's in Mechanical Engineering, 3+ years pharma or 5+ years regulated manufacturing, and hands-on experience with equipment validation.