Sr Engineer

Sr Engineer

Sr Engineer with experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls. Initiate, revise, and approve manufacturing-controlled documents in the document management system. Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.

Duties:

• Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals. Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development. Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
• Assist in the development and execution of process validation protocols and reports. Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire). Ensure configurations align with process design, GMP requirements, and Amgen guidelines. Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
• Use Application Life Cycle Management (ALM) system during validations and navigate SAP for master data, process orders, production versions, inventory, and bill of materials (BOMs). Ensure SAP-MES PAS/X connectivity, troubleshoot IDoc communication issues, and maintain alignment between SAP and MES configurations, particularly for BOM accuracy and process integration.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support. Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.

Requirements:

• Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience.
• Bilingual (Spanish/English)(Write/Speak)
• Computer Literacy