Country United States
City Irvine, California
Functional Area Operations
Job Group Engineering
Employment Type Permanent Contract
Working time Full-time
The Siegfried Group is a global life science company with a network of 12 sites across Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried has sales of 1.3 billion USD and employs over 3,600 people. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN).
The position
Our site in Irvine has been part of Siegfried since 2012 and counts around 150 employees. It is our sterile drug product manufacturing site in the US and provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels.
Within this context, we are currently looking to fill the position of Automation Engineering Lead.
If you're a seasoned professional with a passion for automation, problem-solving, and team collaboration, we want to hear from you!
Your role
As Automation Engineering Lead, you will have a key role in our organization, lead automation projects, contribute to the development of an automation strategy, and drive efficiency improvements in our production facility. You will report directly to the Head of Engineering and will have the supervision of an Automation Technician.
Your tasks:
- Lead end-to-end automation projects, ensuring compliance with cGMP and ISO requirements, and assist in transferring manufacturing processes to the production floor
- Identify and implement modifications to enhance efficiency in manufacturing process control systems
- Design and integrate controls and equipment to optimize automated manufacturing and filling lines
- Document and maintain comprehensive records of assignment activities in laboratory notebooks, ensuring compliance with SOP’s, GMP’s, and regulatory requirements
- Track and analyze performance data, providing recommendations and implementing solutions
- Develop manuals, drawings, or schematics reflecting the current state of control and HMI systems
- Formulate a comprehensive automation strategy for aseptic product formulation, filling, and packaging, offering technical support to technicians and suppliers
- Troubleshoot and resolve problems with the process and process control equipment and fixtures, with the support of a technician
Your profile
- Bachelor's Degree in Engineering, preferably electrical or mechatronics
- 10 years of industrial experience, with a focus on machine building and automation
- Proven experience with PLCs (AB, Modicon, OPTO, Siemens) and machine integration
- Familiarity with OMRON electrocam, LinMot linear motors, stepper motors, and servo motor controls.
- Ability to thrive in a team environment with excellent oral and written communication skills.
- Demonstrated hands-on technical ability with a strong sense of reason and judgment
- Experience in the pharmaceutical, life science or MedTech industries preferred
Working at Siegfried
- Medical, Dental, Vision
- Employer Sponsored Life & AD&D, Long & Short-Term Disability Insurance Plans
- Voluntary Life & AD&D, Accident and Critical Care Insurance Plans
- 401K Retirement Program with Matching
- Generous Paid Time Off, Sick Time and Paid Company Holidays
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