Process Engineer II

Your Role

The Process Engineer II within Manufacturing Science & Technology 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 the 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.

• Support technology transfers as a subject matter expert overseeing transfer of processes from client’s process development to GMP manufacturing for new product introduction.
• Contribute to technical evaluation of new processes, technologies, methods, or materials and facilitate related innovation focusing on delivering customer needs and a GMP product.
• Own knowledge of pharmaceutical manufacturing process technologies used in scale‑up, scale‑down, and DoE design.
• Participate in creation of manufacturing procedures and SOPs for new processes and products.
• Own and support process validation studies and data/trend analysis.
• Responsible for robustness and capability of manufacturing processes developed using statistical analysis to create and monitor CPPs and CQAs.
• Own deviations, CAPAs, and audit responses.
• Support on‑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.

• Strong understanding and hands‑on experience in GMP manufacturing or process development of parenteral products, including 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.

$115,000 – $125,000

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• 401(k)