Process Engineer II

Siegfried•Irvine, CA

About The Position

The Process Engineer II works within the Manufacturing Science & Technology (MS&T) Department, providing expertise to support pharmaceutical process development, technology transfers, and commercial products. The role oversees implementation of new technologies by designing, planning, executing, and interpreting scientific reports or experiments, and contributes to continuous process improvement and innovation at the Irvine manufacturing site. This client-facing position requires advanced proficiency in late-stage process development or clinical and commercial manufacturing operations, along with excellent interpersonal skills.

Requirements

Bachelor’s degree in Engineering or a science-related field and six years of industry experience, or a master’s degree and four years of industry experience; equivalent education or experience may substitute.
At least three years of experience in Fill/Finish or Aseptic Process operations, preferably in clinical or commercial GMP manufacturing.
At least three years of experience bringing pharmaceutical equipment, processes, or methods from development to GMP operational readiness.
Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products, including pharmaceutical or biologic quality attributes and manufacturing controls.
Working knowledge of risk-based decision-making and stage-appropriate strategies for clinical manufacturing, technology transfers, and commercial manufacturing.
Ability to work with global and cross-functional teams in dynamic, time-bound environments.
Ability to build effective working relationships across QA, Project Management, Business Development, and Manufacturing to support new processes and products.
Experience with root-cause analysis and product-quality impact assessments for deviations and investigations, using Lean and Six Sigma tools.
Strong problem-solving skills, including identifying issues, providing solutions, and forward thinking.
Ability to communicate effectively with internal and external clients about technical feasibility and GMP readiness.

Nice To Haves

Working knowledge of GMP production-related IT systems such as SAP and LIMS.

Responsibilities

Support technology transfers as a subject matter expert, overseeing transfer of processes and technologies from client process development to GMP manufacturing for new product introduction.
Contribute to technical evaluations of new processes, technologies, methods, and materials, and facilitate innovation to meet customer needs and deliver GMP products.
Apply knowledge of pharmaceutical manufacturing technologies to scale-up, scale-down, and design of experiments (DoE).
Participate in creating manufacturing procedures and SOPs for new processes and products.
Own and support process validation studies and data and trend analysis.
Assess manufacturing process robustness and capability 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.
Collaborate with global and site partners and customers, including Validation and Analytical Development.
Develop presentations and proposals for potential clients, including project evaluations and technical feasibility assessments.
Build scientific knowledge and technical expertise within and beyond the MS&T department.
Provide technical training and mentorship to junior MS&T members and manufacturing operators.