Sr. Spclst, Engineering

Job Description

Position Summary

The Senior Mechanical Engineer is a key technical leader responsible for the design, startup, commissioning, qualification, operation, reliability, and lifecycle management of the Wilmington site's Central Utility Building (CUB) and critical utility infrastructure. As part of a greenfield biologics manufacturing campus, this role bridges project execution into commercial operations while ensuring safe, reliable, compliant, and sustainable utility performance.

Key Responsibilities

• Provide mechanical engineering leadership during design, construction, commissioning, qualification, startup, and commercial operations of the Central Utility Building (CUB).
• Serve as the engineering owner for critical utility systems including boilers, chilled water, cooling towers, HVAC, compressed air, instrument air, condenser water, domestic water, plant water distribution, condensate recovery, and utility distribution networks.
• Critical utilities Compressed Air, HVAC, purified water, WFI and Clean Steam.
• Provide 24/7 technical support for utility and facility systems, leading troubleshooting of complex mechanical issues.
• Review engineering packages, P&IDs, specifications, calculations, and construction documents for compliance with our Company's engineering standards and cGMP requirements.
• Support FAT, SAT, CQV, operational readiness, and equipment turnover activities.
• Develop preventive, predictive, and reliability-centered maintenance strategies to maximize equipment availability.
• Lead Root Cause Analysis (RCA), failure investigations, and continuous improvement initiatives.
• Own and maintain engineering documentation including P&IDs, equipment files, drawings, maintenance strategies, and asset hierarchies.
• Coach technicians and junior engineers while serving as the site's mechanical utility subject matter expert.
• Partner with Manufacturing, Maintenance, Reliability, Automation, Quality, EHSS, Validation, and Capital Projects to ensure operational excellence.
• Drive energy optimization, sustainability, asset lifecycle planning, and long-term infrastructure reliability.
• Maintain inspection readiness and compliance with cGMP, OSHA, environmental regulations, and corporate engineering standards.
• Support future capital projects, infrastructure expansion, and lifecycle replacement planning.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline.
• 8+ years supporting pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Strong expertise with boilers, chillers, HVAC, compressed air, pumping systems, heat transfer systems, and mechanical utilities.
• Experience with greenfield projects, commissioning, startup, and operational readiness.
• Knowledge of CMMS systems, reliability engineering, and asset management.
• Excellent communication, leadership, and mentoring skills.

Preferred Qualifications

• Experience supporting biologics or sterile manufacturing facilities.
• Knowledge of CQV, FAT, SAT, ISA, ASME, NFPA, OSHA, and cGMP standards.
• Professional Engineer (PE) and/or CMRP certification preferred.
• Experience with Building Automation Systems and sustainability initiatives.

Leadership Competencies

• Technical excellence and sound engineering judgment.
• Collaborative leadership and talent development.
• Commitment to safety, quality, compliance, and operational excellence.
• Ability to thrive in a fast-paced greenfield environment while building sustainable engineering systems.

Required Skills:

Biotechnology, Biotechnology, Capital Projects, Compressed Air, Coordination of Trades, Corporate Productions, Cost Effectiveness Analysis, Decision Making, Design for Manufacturing (DFM), Engineering Document Management, Engineering Standards, Equipment Installations, Estimation and Planning, Fabrication Management, HVAC Systems, Interpersonal Relationships, Maintenance Supervision, Manufacturing Environments, Manufacturing Quality Control, Manufacturing Scale-Up, Mass Production, Mechanical Engineering, Mechanical Principles, Operational Excellence, Pump Systems {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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