Siegfried Holding AG Irvine , CA 92606
Posted 2 months 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
Responsible for supervising the daily operations (products and people), in a unit. Ensuring the adherence to all regulatory and safety requirements and fulfilling production output, quality and time requirements. Develop and maintains a team environment with high levels of participation from all production associates. Responsible for the aseptic filling of all products assuring processes are performed in compliance with cGMP's and following Standard Operating Procedures (SOPs).
Responsibilities
Responsible for scheduling and supervising designated operations
Participate in planning production actives
Ensures that personnel is effectively utilized to meet production needs
Ensure compliance with GMP, ISO 90001, regulatory requirements, dept/bldg. Safety rules and applicable company policies and procedures
Utilize human resources effectively, train and coach and provide developmental opportunities for personnel to increase cross training and scheduling flexibility
Evaluate the performance of personnel; recommend salary and or promotional actions. Take appropriate actions to resolve marginal performs.
Maintain a positive working environment that encourages personnel participation, team work and mutual support
Coordinates actives with materials managements, QA and engineering to insure production, productivity and quality standards are met.
Responsible to implement safety policies and ensure that personnel are trained in and follow safe work procedures
Ensure proper maintenance and work place organization of equipment and work area
Maintain and supply raw material budgets within approved levels.
Set goals and measures with the Manufacturing Manager. Work with minimal supervision to perform duties and assignments. Seeks input and guidance on complex problems or new activities
Solve and trouble shoot routine daily operations problems.
Empowered with authority to act, by making decisions that ensure the safety of all personnel.
Make decisions that ensure the quality and integrity of the product.
Your profile
Required Knowledge, Skills and Abilities
Understanding of lot control relative to medical industry
Understanding of Good Manufacturing Practices and ISO Standards
Ability to lift 50 pounds
Good communication and interaction skills
Ability to work overtime as necessary
Computer literate
Ability to handle multiple tasks
Ability to interact with numerous departments
Ability to work without independently and delegate tasks as necessary
Required Education and Experience
Minimum High School graduate or equivalent
Preferred Bachelor's degree in Science or Engineering
Preferred 3-5years' industry experience directly associated with aseptic manufacturing
Preferred 2 + years related supervisory experiences
Equivalent combination of education and/or experience may be considered
Salary Range: $90,000
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
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