Facilities Engineer

Overview

Lead reliability, design, maintenance and compliance of cGMP facilities and utility systems.

Key Responsibilities

• root cause
• electrical systems
• design review
• equipment qualification
• risk assessment
• data analysis

Tasks

The Facilities Engineer will provide technical leadership and expertise supporting production operations in the areas of reliability, design, maintenance, and cleaning of facilities, water, and micro. Assist with process optimization, equipment qualification, equipment capability studies, asset management, and metrology. -Conduct root cause analysis for equipment and operational events and other technical documents. -Investigates, troubleshoots, and provides repairs to electrical systems, controls, motors, emergency generators, switchgear, variable frequency drives, substations and MCCs. -Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. -Support, develop and maintain the basis of safety for process equipment. -Carries out all duties in compliance with all company, state and federal regulations and guidelines including FDA, EPA, and OSHA. -Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team. -Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose. -Provide engineering support for Task Risk Assessments (TSAs) and Job Hazzard Analysis (JSAs). -Comply with all company and/or site policies and procedures -Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. -Participate in Maintenance projects as required including but not limited to Root Cause Analysis, FMEA’s, and Non- Conformance investigations -Provide technical oversight of ongoing equipment qualification requirements. -Apply statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles.

Requirements

• bachelor's
• cgmp
• deltav
• plc
• scada
• 8+ years

What You Bring

-Bachelor's Degree in Mechanical, Process, Chemical, Biochemical Engineering or related applicable discipline -Strong analytical and problem-solving abilities to address complex challenges proactively. -Excellent communication, leadership, and interpersonal skills to effectively manage cross-functional teams and liaise with clients. -Strong knowledge of regulatory requirements, industry standards, and best practices in cGMP. -8+ years of experience in API and/or cGMP Filling/Packaging Operations -Experience in Aseptic operations, contamination control studies, and QC micro. -Experience of Delta V, PLC and SCADA systems -Experience calibrating and repairing instrumentation associated with GMP utility and non GMP utility systems. -Knowledgeable working with HVAC systems. -Experience in operating and maintaining utility equipment including, but not limited to: Boilers, Chillers, Air Compressors, WFI water systems, Clean Steam generators, Air Compressors, Air Handling Units, CIP skids, and Waste Neutralization. -Working knowledge of utility equipment from an operation and manufacturing impact perspective. -Experience executing predictive and preventive maintenance on GMP and non-GMP utility equipment.

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Benefits

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance. Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

About Clark & Enersen

-Grew steadily across multiple U.S. regions and now operates from offices including Nebraska, Missouri, Kansas, Colorado, Oregon, and South Carolina. -Built its reputation through a wide-ranging portfolio: community libraries, research labs, government facilities, campus buildings and more. -Offers fully integrated services including architecture, civil/mechanical/electrical/structural engineering, landscape, interior design, planning, lab design, energy modeling and digital experience. -Known for designing sustainable systems—from LEED Platinum public works to sites delisted from impaired‑waters lists—through integrated planning and green infrastructure. -Typical projects include higher‑education science centers, government buildings, corporate facilities, healthcare and civic infrastructure with strong technical and design integration. -Standout feature: the firm’s digital experience design team blends architecture and low‑voltage tech—including AV, IT, telecom and electronic security—for future‑ready built environments. -Unusual fact: their stormwater and sustainability work led to Antelope Creek being delisted from the EPA’s impaired‐waters list for E. coli.

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