Senior Plant Engineering Manager - FDA/Pharma Facilities

ROMIL JIMENEZ

Saint Johns, FL • 415-***-**** • *************@*****.***

Manager, Plant Engineering / Maintenance – FDA-Regulated Facilities

PROFESSIONAL SUMMARY

Mechanical Engineer with 24+ years of Engineering & Facilities Maintenance Management in FDA-regulated biotech/pharma manufacturing.

Expert in Clean & Black Utilities, Commissioning/Qualification (CQV), startup projects, CAPEX execution, CMMS, GMP compliance, and team leadership.

Completed 6 major facility startups (up to 1.25M sq ft). Strong experience leading maintenance teams, optimizing utilities, developing SOP/URS/CTPs, and improving OEE using RCM/TPM.

CORE STRENGTHS

Clean & Black Utilities (WFI, Clean Steam, RO/DI, PSG, MES, CT, CHW, CDA, BMS/EMS)

Commissioning, Qualification & Validation (IQ/OQ/PQ, CTPs)

Preventive & Predictive Maintenance CMMS (Maximo, Blue Mountain)

CAPEX & Startup Execution Project Management

GMP, FDA, OSHA, EPA Compliance

Leadership: Training, team development, vendor management

Lean 6S, Six Sigma, OEE improvement

PROFESSIONAL EXPERIENCE

Fujifilm Diosynth Biotechnologies – NC

PM Startup Lead – Clean & Black Utilities Dec 2024 – Present

Lead CQV startup engineering team for all clean/black utility systems.

Review/design URS, CTPs, SOPs for WFI, RO, PSG, CT, CHW, CDA, BMS/EMS, etc.

Develop predictive & preventive maintenance strategies for new facility startup.

Perform FATs, value engineering reviews, and readiness for operations.

Resilience Pharma – Alachua, FL (Department of Defense)

Facility Maintenance Engineer May 2024 – Dec 2024

Led maintenance and PM/PPM execution across clean & dirty utilities.

Created SOPs and URS for WFI, PSG, RO, MES, HVAC, and utility systems.

Executed facility-wide CTPs; resolved WO issues to ensure manufacturing readiness.

Oversaw mechanical vendor bids and provided technical support across engineering, CQV, EHS, and capital projects.

SHL Medical – North Charleston, SC

Head of Facility Maintenance Jan 2023 – Apr 2024

Led total clean/black utilities O&M for a medical device manufacturing facility.

Supported facility buildout, CQV activities, VMP/VP/CTP reviews, and SOP creation.

Managed $2.5M annual maintenance budget; implemented cross-functional initiatives.

Ensured utility reliability, safety compliance, and operational readiness.

Resilience Pharma – Alachua, FL (Sr. Consultant, DoD)

CQV Engineer Jan 2022 – Jan 2023

Led startup of clean and dirty utility systems.

Executed IOQ/PQ for WFI, MES, PSG, RO, HVAC, freezers, and facility utilities.

Developed SOPs, URS, and commissioning plans for full utility infrastructure.

Stevanato Group – Piombino Dese, Italy / Fisher, Indiana

Plant Maintenance, Operations & Engineering Manager Feb 2021 – Dec 2022

Designed and led utility/infrastructure strategy for $366M new syringe manufacturing facility.

Owned all utilities: WFI, Clean Steam, CDA, HVAC, Waste Systems, Chillers, etc.

Executed VEMP for cost control and negotiated utility provider incentives.

Reviewed technical submittals (URS, P&IDs, IQ/OQ/PQ) for facility qualification.

EDUCATION

BS Mechanical Engineering – FEATI University, Manila, Philippines

CERTIFICATIONS

Advanced RO Troubleshooting, Maintenance & Cleaning – David H. Paul

MES & PSG Advanced Maintenance/Operation – Paul Muller

American Management Association: Time Management, Coaching, Management Skills for Managers

Contact this candidate