Demo

Project Engineer

Siegfried
Irvine, CA Full Time
POSTED ON 12/31/2025
AVAILABLE BEFORE 2/7/2026
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Your Role:

Scope and Purpose of Position

The individual will lead CAPEX and other engineering projects, supporting the site in developing new products and processes that meet GMP/ISO 9000 requirements.

Your Profile:

Responsibilities

Provide support to the engineering department by leading CAPEX projects Identifies potential manufacturing process or product improvements to develop efficient manufacturing methods and products. Conduct engineering investigation and support assigned CAPAs for equipment and facility. Provide support in writing maintenance and calibration procedures for equipment and facility. Provide technical support to the maintenance department for equipment and facility troubleshooting and repair. Provide technical support to the Project Managers Develop/review/maintain/update related documentation, files, procedures, databases, drawings and schematics as part of product development and project execution Coordination and execution of Factory Acceptance Testing of equipment Develop the project plan, overseeing the execution of project field upgrades Coordinate with teams to identify, prioritize and track risks to improve product quality Monitor each stage of the project and facilitate communication and interaction amongst the team and cross-functional representatives. Document and present detailed estimates of cost, time, and capability, track project schedules and deliverables against goals. Makes engineering recommendations and implements solutions. Trains operators, assemblers, and inspectors on process and inspection techniques as required. Reviews historical data of existing process equipment or product performance on a regular schedule basis. Simulate process and product models for evaluation, improvements and enhancements. Interfaces with engineers, technicians, customers and suppliers providing technical support as needed. Analysis of current capabilities and development of plans to address shortcomings. Improve fill rates by streamlining MRB processes and rapidly reducing backlogs of quality issues. Create and manage pertinent construction documentation such as submittals, RFI’s, change orders, notifications and correspondence. Other duties assigned by the supervisor.

Project Management:

Project management of internal and external (client) projects, Lead design and development reviews with cross-functional team, including client representatives. Reads and interprets master batch records and product blueprints and documentation as required to perform task.

Process and Product Transfers:

Assists in transferring manufacturing processes and products to production floor by training operators on new equipment and SOP procedures. Provide on line support during the start up to assist them in learning new process Troubleshoots and resolves problems with the process equipment and fixtures Conceptualizes and sketches process/product improvement fixtures. Coordinates the development and fabrication of these fixtures. Modifies existing specifications to describe new equipment and fixture capabilities to creates and updates protocols to establish and document processes and procedures using established company software packages Interprets and follows test protocols to generate data needed to assess process or products reliability Write Change Notice to change or modify existing documents, processes or methods in order to correct problems or accommodate changes in procedures. Delivers presentations at meetings and Concept/Design Review to apprise management of project status.

Required Knowledge, Skills And Abilities

  • Ability to function well in a team environment.
  • Excellent Microsoft Power Point skills
  • Proven experience using Microsoft Project
  • Strong oral and written communication skills.
  • Must interface well internally and with customers
  • Strong leadership skills
  • Superior analytical skills and computer skills.
  • Must be capable of using good reason and judgment to, make and defend recommendations
  • Demonstrate hands on technical ability.

Required Education And Experience

  • Bachelor of Science Degree in Mechanical Engineering, Chemical Engineering or related field
  • 2-4 Years of Industry related experience

Target Salary: $115,000 - 130,000

Your Benefits:

Paid Time Off, Health Insurance, Retirement Planning

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Salary : $115,000 - $130,000

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