Process Expert

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

Goal/Mission

Continuous improvement of processes related to Pharmaceutical manufacturing. Within the assigned PxLTs (Project/Program Leadership Teams), the job holder is the subject matter expert and the responsible representative of (sterile) production with an active reporting line to the department and to the disciplinary supervisor. They are responsible for the processes for new product launches and for monitoring the products assigned to them in their program.

Particular attention is paid to the process steps that are the cause of deviations/complaints, as well as to the continuous improvement of the reliability and efficiency of the manufacturing processes in the. If required, they also lead a product management team or responsibly represent the production in a PxLT meeting. International best practice sharing as part of individual development and process improvements.

Responsibilities

• Provision of technical support for daily preparation processes as well as for the introduction of new processes/technologies in the department / on the site.

• Support in the qualification and validation of plants and processes.

• Technical support in the processing and investigation of com-plaints/technical deviations as well as problems with materials, prod-ucts, processes, and their documentation, including corrective and preventive measures.

• GMP-compliant implementation of changes in the field of manufacturing

• Continuous representation of the department during customer project implementation

• Coordinating changes and requests for products that are not as-signed to a program and forming a Product Leadership Team

Your profile

Required Education and Experience

• University degree in engineering, pharmaceutical technology, chemistry, pharmacy or equivalent scientific qualification (Master of Science or equivalent)

• At least 2 years of experience in a process support function in GMP (Good Manufacturing Practice) and/or Quality Assurance/Quality Control (QA/QC)

• Process knowledge of the pharmaceutical industry

• Good knowledge of local language and English

• Ability to work in a team, focus on results, analytical, conceptual and operational skills

• Optional: Experience in project management

• Ideally knowledge of the generally applicable guidelines (ICH, EU-GMP guideline, pharmacopoeias)

Target Pay Ranger: $75,000-90,000/year

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