Specialist, Engineering, Maintenance & Utilities

Merck; West Point (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Engineering Maintenance & Utilities Specialist to support manufacturing operations. The role involves equipment maintenance, compliance with GMP, and collaboration with engineering teams to enhance operational efficiency. Candidates should possess a B.S. in Engineering and relevant experience in troubleshooting and continuous improvement.

Qualifications

• Minimum 2 years relevant experience including troubleshooting and continuous improvement.
• Ability to work independently and in teams.

Responsibilities

• Support and monitor equipment performance.
• Develop improvement plans for equipment and facilities.
• Champion preventive and predictive maintenance programs.

Skills

Problem-Solving

Communication

Teamwork

Leadership

Flexibility

Education

B.S. in Engineering

4-year Engineering Technology Degree

Tools

CMMS systems

SAP

EAM

Maximo

Job description

Job Description

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

Accountability

Under the supervision of a Senior Specialist or Associate Director, this individual provides day-to-day equipment and facility engineering support for their assigned area. Ensures compliance with GMP, Safety, and Environmental regulations while achieving cost goals. Areas may include vaccine manufacturing, formulation/filling, lyophilization, packaging, and support utilities like power, HVAC, steam, WFI, and temperature-controlled units.

Assigned Tasks

1. Support and monitor equipment performance
2. Perform equipment maintenance
3. Develop improvement plans for equipment and facilities
4. Troubleshoot process equipment for reliable and compliant operations
5. Execute lock-out tag-out (LOTO) procedures

Duties

1. Provide engineering support for equipment, instrumentation, robotics, and utilities
2. Assist and lead troubleshooting efforts and investigate system failures
3. Maintain adequate spare parts inventory
4. Facilitate maintenance work, including JSA/LOTO and spare parts management
5. Ensure CMMS/EAM data accuracy and support maintenance planning
6. Optimize scheduling of preventative, predictive, and corrective maintenance
7. Develop and present metrics for business operations
8. Champion preventive and predictive maintenance programs, analyze reliability, and identify improvement opportunities
9. Collaborate with operations and other engineers to maximize equipment capacity and reliability
10. Provide supervisory coverage as needed
11. Promote open communication and teamwork
12. Maintain technical knowledge and support GMP, safety, and environmental compliance programs
13. Support productivity improvement and deviation resolution, including root cause analysis
14. Develop and improve business processes and system improvements
15. Create qualification, SOP, and maintenance documentation, and generate reports
16. Serve as project engineer for scope development, design, execution, and testing
17. Build relationships with site operations for compliance and operational issues
18. Enforce GMP, safety, and environmental regulations
19. Assist in audits, inspections, and training
20. Author SOPs and user manuals, and support training development
21. Assist in process studies, standards, and profit planning

Qualifications

Essential

• B.S. in Engineering, Science, or a 4-year Engineering Technology Degree
• Minimum 2 years relevant experience including troubleshooting, work facilitation, continuous improvement, data management, and LOTO
• Ability to work independently and in teams
• Proficiency in leadership, flexibility, motivation, teamwork, problem-solving, communication, and computer skills
• Knowledge of engineering standards (ASME, IEEE, NFPA, CFR 1910, NIST, ANSI)

Preferred

• Knowledge of cGMP for pharmaceuticals/vaccines
• Lean Six Sigma, Root Cause Analysis, FMEA
• Reliability engineering and asset lifecycle management
• Experience with CMMS systems like SAP/EAM/Maximo
• CMRP certification

Note: This description aims to outline the general duties and may include other responsibilities as assigned.