Siegfried Holding AG Irvine , CA 92606
Posted 2 weeks ago
General Information
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
Scope and Purpose of Position
This position requires knowledge and ability to perform duties related to the manufacturing of drug, aseptic, device and assembled products utilizing reliable methods according to established procedures. Responsible for performing various duties in the manufacturing, inspection and documentation of producing such products.
Responsibilities
Completes training modules regarding gowning techniques for the entrance to and from designated areas.
Ability to assess the process being performed to ensure consistent quality product is being delivered.
Ability to perform product visual inspection through a use of a high magnification microscope to ensure product meets specification criteria. Ability to demonstrate a high level of detail to determine acceptability.
Technical ability to operate a 200X magnification microscope.
Ability to demonstrate the use of a robotic arm and set the appropriate technical parameters.
Train new hires and/or associates when needed and is able to clearly communicate the activities to be performed.
Ability to demonstrate the use of small tools to manually assemble a hand piece delivery device in accordance with company procedure.
Demonstrate the ability to formulate pharmaceutical grade drug product with strict adherence to company procedure.
Ability to demonstrate the use of an Analytical and/or Micro Balance and have a clear understanding of weight values such as grams, milligrams and micrograms.
Ability to demonstrate and operate use of equipment as required.
Ensures good documentation practices in the recording of data, organizing of batch records, forms, logbooks and any other associated documents for responsible areas.
Assists other team members in manufacturing areas when needed.
Maintain good work place organization and housekeeping.
Responsible for adhering to applicable FDA, SOPs, cGMP and ISO clean room manufacturing rules and regulations related to the position.
Any and all other related duties as assigned by immediate supervisor.
Your profile
Required Knowledge, Skills and Abilities
Ability to read, write and communicate in English to the extent necessary to perform the job function
Good team and problem solving skills
Ability to demonstrate manual dexterity
Ability to stand continuously for two or more hours
Ability to work safely with moving equipment.
Ability to calculate proportions and simple mathematical skills.
Ability to work overtime as necessary
Required Education and Experience
Pay Range: $25-26/hour + 10% Shift Differential when working on 2nd Shift
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
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
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
Siegfried Holding AG