Senior Engineer, Process Engineering

AstraZeneca • Redwood City, CA

1d

About The Position

• Expertise in equipment and manufacturing process, capability to support multiple process areas • 3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance • Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery • Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes. • Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area . • Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering . • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance. • Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization. • Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency. • Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems • Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians • Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area. • Participate in communications with relevant internal teams (e.g., regulatory) for management of change control. • Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. • Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management • Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness • Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management • Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation • Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business

Requirements

• Bachelor's degree in Chemical or Mechanical Engineering
• Minimum of 3 years relevant experience.
• Breadth of experience to establish credibility with key stakeholders.
• Industry experience in a GMP environment
• 3+ years of leadership and project management skills
• Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery

Nice To Haves

• 5 years of relevant experience
• Large Capital project management and execution experience
• Lean certification
• Experience with automatic process controls
• Root cause investigation training/ 6-simga
• TPM experience
• Experience with spray-drying technology
• Experience with equipment maintenance
• Experience with regulatory inspections and handling deviations
• Experience working within cross-functional teams.
• Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives.
• Project management track record of delivering projects
• Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps)

Responsibilities

• Expertise in equipment and manufacturing process, capability to support multiple process areas
• Lead executions of Manufacturing related engineering projects
• Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes.
• Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area
• Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering
• Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance.
• Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization.
• Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency.
• Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems
• Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians
• Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area.
• Participate in communications with relevant internal teams (e.g., regulatory) for management of change control.
• Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements.
• Develop contacts across a range of departments and external groups acting as engineering representative.
• Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness
• Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management
• Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation
• Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

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