Automation/ Controls/ CQV Subject Matter Expert with over 20 years of Biopharmaceutical experience. Capital projects leader providing design, construction oversight, start-up, commissioning, qualification, and manufacturing operational readiness. Experienced Maintenance Manager responsible for Automation, Instrumentation, and Controls responsible for automation and metrology deliverables for Biopharmaceutical bulk manufacturing, filling/ finish, GMP Warehouse, Process Development Labs, QC Labs, and Administration Areas.

 

Eduardo has extensive Systems/ Applications knowledge, including Chemical Storage and Distribution, HVAC, Filling, RODI, WFI, Clean Room, Datacenters, Autoclaves, Access Control, Fire Systems, Electrical Distribution, Freezer Room, Fume Hoods, Fuel Distribution, Lighting, Energy Conservation, Hazardous Rooms, and Wastewater Treatment.

 

CQV Support:

• Leads/ Supports the development, execution, and updating of the Integrated Project Schedule (IPS): from Conceptual-Detail Design, Construction, Operational Readiness, CQV, and ready for MFG.

• Supports the development of the Commissioning and Validation Master Plans.

• Responsible for the management of the development, design, planning, execution, review and final sign-off of CQV protocols.

• Manages the execution of the capital engineering strategy to support the Engineering, Procurement, Construction, & Management (EPCM) of Biopharmaceutical Manufacturing Facilities.

• Provides design, CQV, and operational oversight of the Manufacturing Facilities and support areas.

• Supports the development of the MFG Facility Design, Equipment URS, Specification/ Quotation, Purchase, Delivery, Installation, and CQV.

• Supports Validation and URS activities as defined below:

  • Reviews calibration requirements based on URS

  • Reviews in-house and/ or vendor capability for new assets

  • Reviews and approves URS for appropriate accuracy, ranges, and tolerances

  • Drafts/ Reviews/ Approves AMF for new assets, changes, calibration, and PM data

Capital Project Support:

• Responsible for meeting deadlines under a tight timeline and changing priorities.

• Support the Capital Project Strategy, Design, Specification, RFP Procurement, and Project Management.

• Manages the project budget, contracts, and provide performance dashboards.

• Leverages engineering standards in supporting Detail Design of Manufacturing Facility.

• Facilitates/ supports the execution project and safety risk assessments throughout the project.

• Identifies project gaps and escalates remediation plans to the steering team for approval.

• Establishes and manages projects Master Equipment/ System List.

• Utilizes the company library in the development of the Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3’s, Bid Assessments, and Risk Assessments.

Maintenance Management Support:

• Experienced CMMS (Maximo and Blue Mountain) Super user.

• Facilitates Calibration, PM’s and/ or project meetings and functional sub-team by preparing meeting schedules, agenda, minutes, action items list, Gantt charts, and timelines.

• Provides Engineering SME oversight and response to the equipment/ instrument deviation, out-of- specification reports and investigations, and racking the effectiveness of preventive action.

• Applies Quality by Design principles, experience which aligns with FDA, ICH, and ISPE guidelines.

• Supports Process Mapping and Continuous Improvement activities as defined below:

  • Map out the process flow map (Visio) for each process (Ex. Deviation management, instrument criticality, asset configuration data)

  • Streamline/ improve the current processes and get the buy-in from various stakeholders including QA and leadership

• Manages the PM, HEPA certification, calibrations & equipment repairs as defined below:

  • Ensure the PM, Calibration, Repairs, & HEPA certification are completed per SOP

  • Update the site on the status of equipment/ systems status

  • Coordinate with MFG, ENG, and QA in the scheduling PMs, Calibrations, Repairs, & HEPA Certifications

  • Ensure the Calibration vendor executes the site instrument calibration per the Site Calibration SOP

  • Verify all vendor calibration standards comply with Site SOPs

  • Complete reverse traceability on standards calibration failures

• Complies with the Site CMMS SOPs-Forms and Quality Management System SOPs.