Senior Engineer, Process Engineering (2nd/3rdShift)

AstraZeneca•Redwood City, CA

5d•Onsite

About The Position

Member of the Engineering Team engaged in supporting all manufacturing processes and providing technical support to the Manufacturing Team. The Senior Engineer, Process Engineering (shift) is responsible leading the equipment reliability program, championing continuous improvement, running capital projects, and being the site expert on manufacturing process and systems. The role combines the benefit of small site (agile and broad responsibilities) with the structure, knowledge, and resources of a leading global pharmaceutical company. This is a senior level role where the engineer can assess current state issues, develop plans, initiate projects, and drive execution to eliminate process and equipment issues/failures. This position is 5 days a week onsite, aligned with the manufacturing shift operations (day, swing, or night) and may require after hours or weekend support as required. Typical Accountabilities: Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ. Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance. Ensures compliance with AZ Corporate Policies and Directives. Site Standard Operating Procedures. Regulatory requirements, and industry best practice (cGMPs, GAMP,ITIL,PMI). Maintains a safe work environment and performs work in accordance with site Environment, Health and Safety (SHE) policies and procedures. Manufacturing Process SME Expertise in equipment and manufacturing process, capability to support multiple process areas 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 disciplines equipment, process/materials, maintenance, project delivery Lead investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes. Lead troubleshooting activities to resolve critical escalations, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area Designs studies, executes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering. Track, trend, and analyse 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 cross-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 representatives. Equipment Management: Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness Manages 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

Entry-level Master’s/ PhD degree in engineering, science, technology, or related field (OR) Bachelor’s degree with 3+ years of relevant experience.
Experience working with procedures and compliance with GMP & SHE requirements.
Experience managing process engineering processes (e.g., validation, qualification, operation) across PETs within a highly regulated environment.
Experience in some of the following areas: new technology investigation, process development, capital project execution, and sales product support.
Experience working with digital tools and applications related to reporting, documentation, and analysis.
Industry experience in a GMP environment
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 timely, in-full, and on-budget
Technical role managing project aspects within a specialist area

Nice To Haves

Large Capital project management and execution experience
Lean certification
Experience with automatic process controls
Root cause investigation training/ 6-simga
TPM experience
Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps)
Experience with spray-drying technology
Experience in the following areas: Process scale up; validation activities for commercial production; feedstock and drying processes; and, setting up new equipment– (URS, PID, DQ, IQ, OQ, PQ)

Responsibilities

Lead executions of Manufacturing related engineering projects
Lead investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes.
Lead troubleshooting activities to resolve critical escalations, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area
Designs studies, executes experiments/protocols and perform data analysis.
Develop and optimize processes within own area of process engineering.
Track, trend, and analyse in-process data using statistical process control (SPC) methods.
Monitor and improve process performance.
Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency.
Collaborates with cross-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.
Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness
Manages 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