Process Engineer II

Siegfried•Irvine, CA

1d•$115,000 - $125,000

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: 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.

Requirements

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.
Bachelor's Degree in Engineering or science-related field with six years of industry experience or Master's degree with four 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.

Responsibilities

Support 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.
Contribute to 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).
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 a collaborative culture with key partners (Global and Site) and customers, including Validation, Analytical Development.
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.