ZL01-101525 Sr Engineer
hace 6 días
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Senior Engineer
Education
Doctorate OR
Masters + 2 years of Engineering experience OR
Bachelors in Engineering + 4 years of Engineering experience.
Attributes
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.
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.
Show more Show less
-
Sr. Engineer
hace 6 días
Juncos, Puerto Rico Amgen A tiempo completoJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic...
-
MV01-081225 Sr Engineer
hace 6 días
Juncos, Puerto Rico Validation & Engineering Group, Inc. A tiempo completoValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual...
-
Juncos, Puerto Rico Validation & Engineering Group, Inc. A tiempo completoValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual...
-
ZL01-091024 Engineer
hace 6 días
Juncos, Puerto Rico Validation & Engineering Group, Inc. A tiempo completoValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual...
-
Sr. Engineer
hace 6 días
Juncos, Puerto Rico FITS, LLC A tiempo completoFor Validation services in the Engineering area.WHAT MAKES YOU A FIT: The Technical Part:Bachelor's Degree with four (4) years of experience as an Engineer within the pharmaceutical or regulated industry.Bilingual (English & Spanish).Project Management skills.Shift: Administrative, and according to business needs.Be available to support non-standard shifts,...
-
Sr. Manufacturing Engineer
hace 6 días
Juncos, Puerto Rico FITS, LLC A tiempo completoFor Validation services in the Engineering area.WHAT MAKES YOU A FIT: The Technical Part:Bachelor's Degree with four (4) years of experience as an Engineer within the pharmaceutical or regulated industry.Bilingual (English & Spanish).Project Management skills.Shift: Administrative, and according to business needs.Be available to support non-standard shifts,...
-
Sr Engineer
hace 6 días
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoDescription The Senior Engineering Specialist independently leads process optimization, troubleshooting, and engineering initiatives within manufacturing, pilot plant, operational, or capital project environments. This role applies advanced engineering principles to design, implement, and support complex system modifications, process improvements, and...
-
Sr Engineer
hace 1 semana
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe Senior Engineering Specialist independently leads process optimization, troubleshooting, and engineering initiatives within manufacturing, pilot plant, operational, or capital project environments. This role applies advanced engineering principles to design, implement, and support complex system modifications, process improvements, and capital projects....
-
Sr Engineer
hace 6 días
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe Senior Engineering Specialist independently leads process optimization, troubleshooting, and engineering initiatives within manufacturing, pilot plant, operational, or capital project environments. This role applies advanced engineering principles to design, implement, and support complex system modifications, process improvements, and capital projects....
-
Sr Engineer
hace 2 semanas
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoIndependently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process...
