PET PROCESS ENGINEERING MANAGER

AstraZeneca•Canóvanas, PR

About The Position

Lead the Formulation Process Engineering function to deliver safe, compliant, and efficient operations across site oral solid dose (OSD) products. Owns the PET continuous improvement portfolio to improve quality, robustness, and cost while ensuring GMP readiness and audit resilience. Support capacity planning process and deliver required strategies to achieve: Robust Operations: Stable control strategies, and reliable batch execution with minimized deviations and unplanned downtime. Performance and Cost: Improved OEE, yield, cycle time, and structural cost reduction through value engineering and capital investments. Quality and Compliance: Right-first-time performance, effective CAPA closure and strong inspection outcomes Lead technical support on equipment/computer systems operations, troubleshooting and process control thus supporting day to day supply continuity on PET equipment. Talent and Ways of Working: Enable a PET high-performing team with clear stewardship ownership and efective and effiecient PET ways of working embedded. Typical Accountabilities Strategic Operations and Capacity Planning: Support development of capacity and campaign plans; propose service/cost/risk trade-offs aligned with S&OP. Support integrated risk register with mitigations for single points of failure. Technology Strategy and Roadmap: Define and deliver technology roadmaps (e.g., single-use systems where applicable, alarm rationalization, digital batch records/EBR). Identifies, recommends, and implements equipment modifications to ensure improved/optimized process performance. Continuous Improvement Portfolio Leadership: Lead CI portfolio linked to OEE, yield/loss, changeover time, and consumables. Responsible for identifying and lead the execution of projects to reduce product cost, improve product quality, improve yield, and reduce material usage. Collaborates with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability. Quality and Compliance Governance: Through the Process Engineering organization, it provides support for Formulation areas, including investigation and correction of manufacturing quality issues that could potentially lead to a disruption in product supply. Drive deviation/CAPA effectiveness, data integrity and robust change control Ensure alignment with cGMPs and site SOPs; maintain inspection readiness artifacts. Process Monitoring and Digital/Data Strategy: Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results related to product quality and financial aspects. Accountable for defining, executing, and continuously improving the PET digital and data strategy to enhance safety, quality, capacity, and cost performance across manufacturing operations. This includes establishing an aligned vision and roadmap for digital enablement; and delivering value through prioritized use cases. Equipment, Automation: Led the Process Engineering function responsible to provide support of the process control activities (Process controls and equipment/system troubleshooting in day-to-day operations., backup and restore process of systems software, access control management, process controls maintenance, support to computer system validation and qualification) Change Control and Documentation: Through the Process Engineering organization led the process to author/update/review area procedures, master batch records, and EBR steps, ensuring stewardship and compliance. Leadership: Mentor Process Facilitators and other PET to embed PET ways of working Deputize for PET Lead. Stakeholder and External Engagement: Represent in site governance and audits (FDA/EMEA, corporate); act as front-room SME. Engage with internal and external stakeholders as appropriate.

Responsibilities

Support development of capacity and campaign plans; propose service/cost/risk trade-offs aligned with S&OP.
Support integrated risk register with mitigations for single points of failure.
Define and deliver technology roadmaps (e.g., single-use systems where applicable, alarm rationalization, digital batch records/EBR).
Identifies, recommends, and implements equipment modifications to ensure improved/optimized process performance.
Lead CI portfolio linked to OEE, yield/loss, changeover time, and consumables.
Responsible for identifying and lead the execution of projects to reduce product cost, improve product quality, improve yield, and reduce material usage.
Collaborates with Production, Engineering, Automation, and Quality to optimize productivity, yield, product quality, and supply reliability.
Through the Process Engineering organization, it provides support for Formulation areas, including investigation and correction of manufacturing quality issues that could potentially lead to a disruption in product supply.
Drive deviation/CAPA effectiveness, data integrity and robust change control
Ensure alignment with cGMPs and site SOPs; maintain inspection readiness artifacts.
Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results related to product quality and financial aspects.
Accountable for defining, executing, and continuously improving the PET digital and data strategy to enhance safety, quality, capacity, and cost performance across manufacturing operations. This includes establishing an aligned vision and roadmap for digital enablement; and delivering value through prioritized use cases.
Led the Process Engineering function responsible to provide support of the process control activities (Process controls and equipment/system troubleshooting in day-to-day operations., backup and restore process of systems software, access control management, process controls maintenance, support to computer system validation and qualification)
Through the Process Engineering organization led the process to author/update/review area procedures, master batch records, and EBR steps, ensuring stewardship and compliance.
Mentor Process Facilitators and other PET to embed PET ways of working
Deputize for PET Lead.
Represent in site governance and audits (FDA/EMEA, corporate); act as front-room SME.
Engage with internal and external stakeholders as appropriate.