PET PROCESS ENGINEER

AstraZeneca•Canóvanas, PR

About The Position

Provide technical process engineering support for oral solid dose (OSD) formulation operations to ensure safe, compliant, and efficient manufacturing. Execute process monitoring, troubleshooting, and continuous improvement to enhance robustness, quality, and cost performance. Contribute to GMP readiness and audit resilience by maintaining strong documentation, deviation/CAPA effectiveness, and data integrity. Support day-to-day supply continuity across PET operation by resolving issues and optimizing the operation process controls, and implementing changes under site change control. Enable PET ways of working through stewardship of assigned processes/equipment, collaboration across functions, and disciplined execution of improvement projects. Typical Accountabilities Strategic Operations and Capacity Planning: Support capacity and campaign planning by providing process input, risk assessments, service/cost/risk trade-off analyses Technology Strategy and Roadmap: Contribute to technology roadmaps (e.g., PAT deployment, alarm rationalization, digital batch records/EBR improvements, single-use systems where applicable) by evaluating options and supporting implementation.. Continuous Improvement: Execute CI initiatives linked to OEE, yield/loss reduction, changeover time, and consumables optimization. Identify and deliver projects that reduce product cost, improve product quality, enhance yield, and reduce material usage. Model PET ways of working, including disciplined problem-solving and data-driven decision making. Quality and Compliance Governance: Provide technical support to Formulation areas, including investigation and correction of manufacturing technical/quality issues to protect supply continuity. Author or contribute to technical assessments for deviations, CAPAs, and change controls; drive right-first-time outcomes and robust closure. Ensure alignment with cGMPs, site SOPs, and inspection readiness expectations. Process Monitoring and Digital/Data Strategy: Conduct troubleshooting and root-cause analysis for unexpected trends or results affecting product quality or financial performance due to material or process factors. Change Control and Documentation: Author/update/review area procedures, master batch records, and EBR steps to ensure stewardship and compliance. Stakeholder and External Engagement: Represent Process Engineering in internal governance meetings and support audits (FDA/EMEA, corporate) as back-room or front-room technical SME for assigned scope. Engage with internal and external stakeholders, including suppliers, to resolve technical issues and implement improvements.

Requirements

Bachelor’s degree in Engineering (Chemical or Mechanical Engineering preferred) with a minimum of three (3) years related experience and/or training.
Thorough knowledge of the pharmaceutical/medical device industry with emphasis in manufacturing, packaging, utilities, and related equipment (including automation).
Project management experience and proficiency required.
Knowledge and understanding of project management, and change control principles.
Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
Basic knowledge in automation and equipment programs/control
Language: Fully Bilingual (English and Spanish)
Ability to read, analyze, and interpret general business (Business acumen), professional industry trend, including SHE area /technical/GMP and government regulations.
Ability to write business case project proposals, plans, budgets and related project documents.
Ability to write technical (both high and low level) specifications, procedures, plan, and reports.
Ability to effectively present technical information and respond to questions from groups of peers, managers, and customers/stakeholders.
Digital Literacy: Working knowledge of MS Windows Operating Systems. Windows applications such as Word, Excel, Access, Power Point and Project, among others.
Working knowledge on SAP, GVLMS and automation and basic programming.

Responsibilities

Support capacity and campaign planning by providing process input, risk assessments, service/cost/risk trade-off analyses
Contribute to technology roadmaps (e.g., PAT deployment, alarm rationalization, digital batch records/EBR improvements, single-use systems where applicable) by evaluating options and supporting implementation.
Execute CI initiatives linked to OEE, yield/loss reduction, changeover time, and consumables optimization.
Identify and deliver projects that reduce product cost, improve product quality, enhance yield, and reduce material usage.
Provide technical support to Formulation areas, including investigation and correction of manufacturing technical/quality issues to protect supply continuity.
Author or contribute to technical assessments for deviations, CAPAs, and change controls; drive right-first-time outcomes and robust closure.
Conduct troubleshooting and root-cause analysis for unexpected trends or results affecting product quality or financial performance due to material or process factors.
Author/update/review area procedures, master batch records, and EBR steps to ensure stewardship and compliance.
Represent Process Engineering in internal governance meetings and support audits (FDA/EMEA, corporate) as back-room or front-room technical SME for assigned scope.
Engage with internal and external stakeholders, including suppliers, to resolve technical issues and implement improvements.