Project Engineer III

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

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

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.

Your profile

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
5-7 Years of Industry related experience

Target Pay Range: $125,000 - 135,000

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe

The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.

The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.

We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Irvine

Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
All fully cGMP and SHE compliant

Features

Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
Semi-automated and automated visual inspection
Automated packaging with digital data visual verification
Stability study services
Drug delivery
Laboratory services
Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries

General Information