Senior Process Engineer

Your role

Scope and Purpose of the Position

The Senior Process Engineer within Manufacturing Science & Technology (MS&T) department provides Siegfried Irvine manufacturing 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.

Key responsibilities include :

• Lead technology transfers as a subject matter expert overseeing the transfer of processes and technologies from the client's process development to GMP manufacturing to support new product introduction
• Oversee technical evaluation of new processes, technologies, methods, and / or materials and facilitate related innovation focusing on delivering customer needs and a GMP product.
• Own the knowledge of pharmaceutical manufacturing process technologies used in the scale-up, scale-down, and design of experiments (DoE).
• Drive 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

• 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.
• Proven expertise in risk-based decision making and stage-appropriate implementation strategies supporting clinical manufacturing, technology transfers, and commercial manufacturing.
• Proven ability to lead root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean and Six Sigma tools.
• Highly capable of identifying issues, providing solutions, and forward-thinking through solid problem-solving.
• Excellent verbal communication, oral presentation, self-awareness, and the impact of communication and its working style on others.
• Advance use of GMP production-related IT systems such as SAP and LIMS desired. Required Education and Experience
• Bachelor's Degree in Engineering or science-related field with eight years of industry experience or Master's degree with six years of industry experience.
• Minimum three years of experience in Fill / Finish or Aseptic Process operations, preferably in clinical or commercial GMP manufacturing.
• Minimum three years of experience bringing pharmaceutical equipment, process, or methods from development to GMP operational readiness.
• Equivalent education or experience may substitute the stated requirements. Target Salary range - $125,000 - $140,000

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 Across the GlobeThe 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
30+ days ago