Process Engineer II

Takeda • Thousand Oaks, CA

9d • $70,000 - $110,000 • Onsite

About The Position

Under the direction of the Head of Process Engineering, the Process Engineer II is responsible for providing process engineering support for manufacturing operations, investigations, equipment, and projects at the Rancho and Lawrence Manufacturing Facilities. This role independently supports moderately complex engineering activities, drives process improvements, and partners cross-functionally to ensure safe, compliant, and efficient manufacturing operations.

Requirements

• B.S. in Engineering required; Chemical or Mechanical Engineering preferred.
• Minimum 3 years of related experience in a GMP pharmaceutical, biotechnology, or regulated manufacturing environment required; 5 years preferred.
• Working knowledge of engineering principles across relevant disciplines, with the ability to apply them to manufacturing and process engineering problems.
• Working knowledge of cGMP manufacturing, Good Engineering Practices, and regulated pharmaceutical or biotechnology operations.
• Ability to organize and present technical information and project updates with limited assistance.
• Ability to utilize engineering tools to solve moderately complex problems, such as FMEA, process modeling, Design of Experiments, data analysis, and technical problem-solving methods.
• Ability to manage and prioritize multiple assignments across operations, projects, and support activities.
• Strong written and verbal communication skills and the ability to collaborate effectively across functions.
• Demonstrated sound judgment, integrity, work ethic, intellectual honesty, and pragmatism.

Nice To Haves

• Experience supporting manufacturing operations, process improvements, equipment troubleshooting, investigations, and/or capital projects preferred.
• Strong technical writing skills preferred.

Responsibilities

• Establish and maintain engineering discipline and practices that support manufacturing operations while improving functionality, compliance, and efficiency.
• Apply engineering principles to the design and implementation of system modifications, process changes, and capital projects.
• Perform engineering assignments with increasing independence; solve problems, make design recommendations, assess results, and recommend material and process specifications.
• Provide process and equipment engineering support for projects, manufacturing issues, troubleshooting, investigations, and continuous improvement efforts.
• Determine root causes, develop recommendations for corrective and preventive actions, and follow through to ensure effective implementation.
• Analyze existing products and processes and recommend improvements to increase efficiency, improve reliability, and reduce cycle time.
• Lead or support process improvement projects through implementation, including development of training and support for new processes and measurement systems.
• Support equipment qualification activities and coordinate contractors, vendors, and technicians to execute engineering work.
• Track and report project costs, estimate the impact of design or policy changes, and provide recommendations related to capital expenditures and production methods.
• Investigate operational or process-related issues and recommend design or process improvements using sound engineering principles.
• Collaborate with area leadership and cross-functional partners to recommend engineering solutions that support project goals and business objectives.
• Prepare and present technical updates, project summaries, and engineering recommendations with limited guidance.
• Utilize engineering tools such as FMEA, process modeling, data trending, and Design of Experiments to solve technical problems and support decision-making.
• Analyze how process changes may affect production, product quality, compliance, and operational performance.
• Ensure cGMPs, SOPs, company procedures, and Good Engineering Practices are appropriately integrated into all activities.
• May perform other duties as assigned.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees