Country United States
City Irvine, California
Functional Area Operations
Job Group Production
Employment Type Permanent Contract
Working time Full-time
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
This position requires knowledge and ability to perform duties related to the manufacturing of drug products in a cleanroom environment, aseptic, device and assembled products utilizing reliable methods according to established procedures.
Responsibilities include:
- Perform set up activities and operates aseptic filling machines. Perform cleaning activities post fill.
- Assess the process performed, and if necessary, stop a line to ensure a quality product.
- Ensure good document practices in the recording, maintenance, reviewing and organizing of batch records, forms, documents and logbooks for responsible areas.
- Assist other team members in manufacturing areas when needed.
- Maintain good workplace organization and housekeeping.
- Responsible for adhering to applicable SOP, GMP and ISO rules and regulations related to the position.
- Train and instruct personnel to perform tasks following appropriate SOPs.
Positions available on all shifts. Shift differential pay for 2nd and 3rd shifts.
Your profile
Required skills and abilitie:
- Good oral and written communication skills
- Good team and problem solving skills
- Initiative and manual dexterity
- Ability to stand continuously for two or more hours while wearing proper gowning materials
- Ability to work safely and use all material moving equipment in a safe manner
- Basic math skills
- Ability to work overtime as necessary
Required Education and Experience
- High school graduate or equivalent
- A minimum of 1 to 3 years of industry experience
- Pharmaceutical industry experience
- Experience with cGMP and aseptic gowning for ISO 5/6
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