Sr Engineer 34562

Integrated Services For Productivity & Validation, Inc

Job Location:

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 4-5years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Requirements

Doctorate OR Masters 2 years of Engineering experience
OR Bachelors in Engineering 4 years of Engineering experience.

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.