Operating Engineer

Overview

Location: Milpitas, CA 95035

Duration: 3 months CTH

Base pay range: $46.00/hr - $48.00/hr

Company: blue Stone Solutions Group

Job Description: The Chief Engineer serves as the senior technical leader responsible for all facilities operations, maintenance, and regulatory compliance within a critical pharmaceutical manufacturing and laboratory environment. This is a "working" Chief Engineer position requiring hands-on technical execution combined with strategic facility management oversight. The role demands deep expertise in pharmaceutical industry regulations, validated systems management, and comprehensive facilities operations while maintaining the highest standards of GxP compliance.

The successful candidate will lead a multi-disciplinary maintenance team while personally executing complex technical work, ensuring 24/7 facility reliability, regulatory compliance, and operational excellence.

• Lead and oversee all facility operations and maintenance, ensuring the highest standards of regulatory compliance in a pharmaceutical manufacturing environment.
• Personally execute complex technical maintenance, troubleshooting, and repairs on critical systems, including HVAC, boilers, chillers, and pharmaceutical-grade systems.
• Develop and implement comprehensive preventive maintenance programs for all building systems, including HVAC, electrical, plumbing, compressed air, and more.
• Ensure compliance with FDA regulations, GxP standards, and change control procedures, supporting validation protocols for pharmaceutical manufacturing systems.
• Lead facility risk assessments, business continuity planning, and manage operating budgets, vendor relationships, and capital improvement projects.
• Respond to emergency situations with immediate technical assessment and resolution, ensuring minimal impact on production.
• Provide technical leadership to a multidisciplinary team of maintenance technicians, offering guidance, mentoring, and skills training.
• Coordinate emergency response activities and ensure backup systems readiness.

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Facilities Management, or a related technical discipline.
• 8+ years of facilities management experience, with at least 5 years in pharmaceutical, biotechnology, or FDA-regulated environments.
• Hands-on experience with critical systems such as HVAC, boilers, electrical distribution, and specialized pharmaceutical utilities (e.g., Water for Injection, compressed air systems).
• In-depth knowledge of FDA 21 CFR Part 210/211, cGMP, and other regulated systems.
• Proven leadership experience managing maintenance teams, vendor relationships, and large-scale projects with budgets exceeding $1M annually.
• HVAC certifications (e.g., NATE or equivalent), State electrical license, OSHA 30-hour, and other relevant certifications.

• Certified Facility Manager (CFM) or equivalent credential.
• Experience with Building Automation Systems (BAS) and Computerized Maintenance Management Systems (CMMS), preferably with SAP.
• Prior experience in pharmaceutical equipment validation and regulatory inspections.

Mid-Senior level

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