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Project Engineer

Irvine, CA 92618

Employment Type: Perm Job Number: 25441

Job Description

Project Engineer
Salary Range: $115k to $140k 

The Project Engineer is responsible for leading capital projects and key engineering initiatives that support the development, optimization, and implementation of new products and manufacturing processes in a regulated environment. Key Responsibilities Engineering & Technical Support
  • Lead capital improvement projects and drive engineering initiatives that enhance process efficiency and product performance.
  • Identify opportunities for process optimization and product enhancement through analysis and continuous improvement methodologies.
  • Conduct technical investigations and support corrective and preventive actions related to equipment and facility issues.
  • Develop and maintain documentation including procedures, drawings, schematics, and project-related records.
  • Write and update maintenance, calibration, and operational procedures for equipment and facility systems.
  • Provide hands?on technical troubleshooting support to maintenance and operations teams.
  • Assist project managers with technical inputs, documentation, and execution support.
Project Execution
  • Plan and coordinate equipment Factory Acceptance Testing (FAT) and field implementation activities.
  • Build project plans, monitor progress, and track deliverables, risks, and timelines.
  • Facilitate communication between cross functional teams and serve as a liaison for technical discussions.
  • Prepare cost and timeline estimates, manage schedules, and evaluate overall project performance.
  • Develop and implement engineering solutions, and provide training on new processes or equipment as needed.
  • Analyze historical performance data and simulate models to identify improvement opportunities.
Process & Product Transfer
  • Support the transfer of new or updated processes to production by training operators and providing on site support during startup.
  • Troubleshoot issues with process equipment, fixtures, and tooling.
  • Design conceptual sketches for process or product improvement fixtures and coordinate their fabrication.
  • Update specifications and documentation to reflect equipment or process enhancements.
  • Execute test protocols, gather data, and evaluate process and product reliability.
  • Prepare and process change notices related to procedures, methods, or documentation.
  • Present project updates, results, and recommendations to leadership during design reviews and team meetings.
General Responsibilities
  • Collaborate effectively with internal teams, external partners, and suppliers.
  • Create and manage construction related documentation such as RFIs, submittals, change orders, and official correspondence.
  • Contribute to continuous improvement efforts, including reducing quality backlogs and streamlining processes.
  • Perform other duties as assigned by leadership.
 
Required Skills & Qualifications
  • Strong team collaboration and communication skills.
  • Proficiency with Microsoft Project and advanced PowerPoint capabilities.
  • Ability to work effectively with cross functional partners and customers.
  • Strong analytical, organizational, and technical problem solving abilities.
  • Hands-on engineering aptitude and sound judgment in decision making
Education & Experience
  • Bachelor’s degree in Mechanical Engineering, Chemical Engineering, or a related field.
  • 2–4 years of relevant industry experience. Preferably in Pharmaceutical or Medical Device industry

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