Specialist, Engineering, Maintenance & Utilities

MSD; West Point (NE); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a motivated Engineering Maintenance & Utilities Specialist to enhance manufacturing operations. In this pivotal role, you will provide engineering support, ensure compliance with GMP and safety regulations, and champion preventive maintenance programs. You will work collaboratively with cross-functional teams to troubleshoot equipment issues and drive continuous improvement initiatives. This is an exciting opportunity to contribute to a dynamic environment where your expertise will play a key role in optimizing operations and ensuring regulatory compliance.

Qualifications

• 2+ years of experience in equipment troubleshooting and maintenance.
• Proficiency in engineering standards and safety regulations.

Responsibilities

• Provide engineering support for equipment and utilities on the shop floor.
• Collaborate with teams to troubleshoot equipment issues and improve processes.

Skills

Problem-solving

Communication

Teamwork

Leadership

Flexibility

Education

B.S. in Engineering

4-year Engineering Technology degree

Tools

CMMS systems (SAP, Maximo)

Job description

Job Description

Are you a motivated and experienced Engineering Maintenance & Utilities Specialist seeking a challenging and rewarding opportunity? Do you have a passion for driving excellence? We are looking for a growth-minded Specialist to join our team and support manufacturing operations both internally and externally.

ACCOUNTABILITY

Reporting to a Senior Specialist or Associate Director, this role involves providing daily equipment and facility engineering support within your assigned area. Ensuring compliance with Good Manufacturing Practices, safety, and environmental regulations while meeting operating cost goals. Your area may include vaccine bulk manufacturing, formulation/filling, lyophilization, packaging, and utilities such as power, HVAC, steam, WFI, and temperature-controlled units.

Assigned tasks may include:

• Monitoring equipment performance
• Performing equipment maintenance
• Developing improvement plans for equipment and facilities
• Troubleshooting process equipment for reliable and compliant operations
• Executing lock-out tag-out (LOTO) procedures

DUTIES

• Providing engineering support for equipment, instrumentation, robotics, and utilities on the shop floor
• Collaborating with operations, maintenance, automation, and quality teams to troubleshoot equipment issues and investigate manufacturing anomalies
• Maintaining an adequate spare parts inventory
• Facilitating maintenance activities, including leading JSA/LOTO procedures and managing spare parts
• Ensuring CMMS/EAM data accuracy for assigned equipment
• Supporting maintenance planning and scheduling to enhance equipment reliability
• Developing and tracking metrics for business operations and reporting regularly
• Championing preventive and predictive maintenance programs, analyzing equipment history, conducting root cause analysis, and identifying reliability improvements
• Working with cross-functional teams to optimize capacity and ensure compliance with GMP, safety, and environmental standards
• Providing supervisory coverage as needed
• Promoting open communication and teamwork
• Maintaining technical knowledge and supporting safety, GMP, and environmental compliance programs
• Participating in root cause investigations and productivity improvement initiatives
• Evaluating and improving business processes, developing system improvement strategies
• Creating qualification, SOP, and preventive maintenance documentation, and supporting ongoing operations with reports and data
• Managing projects from scope development through design, execution, and commissioning/qualification testing
• Building strong relationships with site operations to ensure regulatory and operational consensus
• Explaining and enforcing GMP, safety, and environmental regulations
• Assisting with audits, inspections, and training in your area
• Authoring SOPs or user manuals and developing training materials for mechanics and supervisors
• Supporting process studies, engineering standards, equipment utilization, and profit planning

QUALIFICATIONS:

Essential:

• B.S. in Engineering, Science, or a 4-year Engineering Technology degree
• At least 2 years of relevant experience, including equipment troubleshooting, facilitating work execution, executing improvement projects, managing maintenance data, LOTO procedures, and working independently and collaboratively
• Proficiency in leadership, flexibility, motivation, teamwork, problem-solving, communication, and computer skills
• Knowledge of engineering standards (e.g., ASME, IEEE, NFPA, CFR 1910, NIST, ANSI)

Preferred:

• Knowledge of cGMP in pharmaceutical/vaccine manufacturing
• Lean Six Sigma, Root Cause Analysis, Failure Mode Effects Analysis
• Reliability engineering and asset lifecycle management
• Experience with CMMS systems like SAP, Maximo, etc.
• CMRP certification

Note: This description provides a general overview and may include additional duties as assigned.