LOTTE Biologics · 11 hours ago
Facilities Engineer
LOTTE Biologics is a new company dedicated to delivering therapies that enable a healthier world. The Facilities Engineer is responsible for the compliant operation and maintenance of GMP-critical facility programs, ensuring continuous inspection readiness and operational excellence in a CDMO environment.
AnalyticsBiotechnologyManufacturing
Responsibilities
Maintain GMP facility programs in compliance with local, state, federal, and international regulations
Ensure inspection readiness of facility systems; serve as SME during audits and regulatory inspections
Develop responses and implement corrective actions for deficiencies identified during audits
Oversee preventive maintenance and repairs for building envelope, pest control, electrical, mechanical, HVAC, cooling towers, and security systems
Coordinate system shutdowns and lead investigations related to GMP-critical systems
Manage third-party vendors and contractors to ensure timely and compliant execution of work
Identify and implement energy conservation, cost savings, and reliability improvements
Drive facility-related capital projects (HVAC, clean utilities, infrastructure upgrades) on time, within budget, and in compliance with safety and client requirements
Perform data analysis, root cause investigations, and implement CAPAs for facility programs
Train and develop in-house technicians and contractors on SOPs and compliance requirements
Build and sustain strong relationships with internal and external stakeholders, including Manufacturing, Quality, HSE, and regulatory agencies
Communicate effectively with clients and internal teams to support inspection readiness and operational excellence
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) or equivalent technical experience required
Experience with GMP compliance, facility systems (HVAC, clean utilities, pest control, GMP cleaning), and capital project execution strongly desired
Familiarity with regulatory requirements (FDA, EMA, OSHA, DEC) and quality systems (change control, investigations, CAPA) required
Technical Expertise in facilities engineering, including mechanical, electrical, HVAC, clean utilities, pest control, and GMP cleaning systems
Strong understanding of GMP regulations, quality systems (change control, investigations, CAPA), and applicable standards (FDA, EMA, OSHA, DEC)
Project Management Skills: ability to manage budgets, schedules, contractors, and capital projects effectively
Analytical and Problem-Solving Skills for troubleshooting complex facility and utility issues
Ability to interpret technical drawings and documentation and ensure compliance with good engineering practices
Effective Communication Skills, including technical writing and presentation abilities for audits, inspections, and cross-functional collaboration
Customer Service Orientation with the ability to build and maintain strong relationships with internal and external stakeholders
Adaptability and Autonomy: capable of working independently in a fast-paced, matrixed environment with minimal supervision
Computer Proficiency in MS Office Suite and familiarity with CMMS or other maintenance management systems
Physical Capability to perform job-related tasks (lifting, bending, overhead work, confined spaces) and willingness to provide on-call/off-hours support as needed
Preferred
4–6 years of progressive experience in facilities engineering, maintenance, or utilities management within a GMP-regulated pharmaceutical, biotechnology, or API manufacturing environment preferred
Project management experience (budgeting, scheduling, vendor oversight) is a plus
Benefits
Target Bonus 10%
Company
LOTTE Biologics
LOTTE Biologics offers end-to-end CDMO services for biopharmaceutical manufacturing, aiming for global top 10 status.
H1B Sponsorship
LOTTE Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
Funding
Current Stage
Late StageRecent News
2026-01-14
2025-12-11
Company data provided by crunchbase