What are the responsibilities and job description for the Process Engineer, II position at Siegfried?
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 the Position
The Process Engineer II within Manufacturing Science & Technology (MS&T) Department provides the site with knowledge and expertise required to support our diverse portfolio encompassing pharmaceutical process development, technology transfers, and commercial products. This individual will oversee implementation of new technologies by designing, planning, executing, and interpreting scientific reports or experiments to contribute to the overall success of MS&T organization. They will also play a key role in driving continuous process improvements and innovation for the Irvine manufacturing site. This client-facing position requires an advanced level of proficiency in late-stage process development or clinical and commercial manufacturing operations as well as excellent interpersonal skills.
Responsibilities
Participate in the creation of manufacturing procedures and SOPs for new processes and products. Own and support process validation studies and the data /trend analysis.
Responsible for the robustness and capability of the manufacturing processes developed using statistical analysis to create and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
Own deviations, CAPAs, and audit responses. Support on-the-floor troubleshooting and root-cause investigations.
Develop potential clients' presentations and proposal generations including project evaluations and technical feasibility assessments.
Your profile
Required Knowledge, Skill, And Abilities
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
Your role
Scope and Purpose of the Position
The Process Engineer II within Manufacturing Science & Technology (MS&T) Department provides the site with knowledge and expertise required to support our diverse portfolio encompassing pharmaceutical process development, technology transfers, and commercial products. This individual will oversee implementation of new technologies by designing, planning, executing, and interpreting scientific reports or experiments to contribute to the overall success of MS&T organization. They will also play a key role in driving continuous process improvements and innovation for the Irvine manufacturing site. This client-facing position requires an advanced level of proficiency in late-stage process development or clinical and commercial manufacturing operations as well as excellent interpersonal skills.
Responsibilities
Participate in the creation of manufacturing procedures and SOPs for new processes and products. Own and support process validation studies and the data /trend analysis.
Responsible for the robustness and capability of the manufacturing processes developed using statistical analysis to create and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
Own deviations, CAPAs, and audit responses. Support on-the-floor troubleshooting and root-cause investigations.
Develop potential clients' presentations and proposal generations including project evaluations and technical feasibility assessments.
- Build scientific knowledge and increase technical know-how within and beyond the MSAT department. Provide technical training and mentorship to junior MS&T members and manufacturing operators.
Your profile
Required Knowledge, Skill, And Abilities
- Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products, including the quality attributes and manufacturing controls for pharmaceuticals or biologics.
- Working knowledge of risk-based decision making and stage-appropriate implementation strategies supporting clinical manufacturing, technology transfers, and commercial manufacturing.
- Capable of working with global and cross-functional teams in dynamic and time-bound environments.
- Capable of building effective working relationships across departments (QA, Project Management, Business Development, and Manufacturing) to support the introduction of new processes and products.
- Experience with root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean and Six Sigma tools.
- Capable of identifying issues, providing solutions, and forward thinking through solid problem solving.
- Able to effectively communicate with internal and external clients on matters concerning technical feasibility and GMP readiness.
- Working knowledge of GMP production-related IT systems such as SAP and LIMS is desired
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
- 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)
- 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
Salary : $108,000 - $118,000
