Process Engineer II

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending & HSA Options

Life Insurance

Short- & Long-Term Disability

Pet Insurance

Generous PTO

Sick & Holiday Time Off

401K

Job summary

Siegfried in Irvine, CA, is seeking a Process Engineer II to support pharmaceutical process development, technology transfers, and commercial manufacturing within MS&T. You will plan, execute, and interpret studies to drive continuous improvements and scale-up on site.

The role requires solid GMP knowledge for parenteral products, experience with DoE, CAPAs, deviations, and collaboration with QA, Project Management, and Manufacturing. Competitive salary and comprehensive benefits available.

Qualifications

• Bachelor’s degree with six years’ experience or Master’s with four years in industry.
• Minimum three years in Fill/Finish or Aseptic Process operations in GMP.
• Minimum three years taking equipment/process from development to GMP readiness.
• Equivalent education or experience may substitute.

Responsibilities

• Own knowledge of manufacturing process technologies for scale-up, DoE, and CPP/CQAs.
• Contribute to manufacturing procedures and SOPs for new processes.
• Support process validation studies and data/trend analysis.
• Improve robustness/capability of processes using statistical analysis.
• Own deviations, CAPAs, and audit responses.
• Assist on-the-floor troubleshooting and root-cause investigations.
• Develop client presentations and evaluate project feasibility.
• Train and mentor junior MS&T members and operators.

Skills

GMP manufacturing

Process development

risk-based decision making

cross-functional teams

root cause analysis

problem solving

communication with clients

GMP IT systems knowledge

Education

Bachelor’s degree in Engineering or science-related field

Master’s degree in Engineering or science-related field

Tools

SAP

LIMS

Job description

"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: 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

• 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.
• Build 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.

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.

Required Education and Experience

• 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.

Target salary range is $115,000 - $130,000 Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Your Benefits:

• Medical
• Dental
• Vision
• Flexible Spending & HSA Options
• Life Insurance
• Short- & Long-Term Disability
• Pet Insurance
• Generous PTO
• Sick & Holiday Time Off
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.