Mechanical Services Engineer, S

Merck KGaA Darmstadt Germany - Durham, NC

Full-time - Entry Level

Onsite - Durham, NC

Chemical Manufacturing

About the position

The Mechanical Services Engineer position is critical in ensuring the reliable performance of equipment within the organization. This role involves providing hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as collaborating with Technology and Quality teams during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives, particularly focusing on Safety, Compliance, and Cost. The Mechanical Services Engineer must possess the ability to self-identify opportunities for improvement and execute tasks with minimal supervision, demonstrating a proactive approach to maintenance and reliability.

Responsibilities

• Analyzes maintenance, equipment and calibration performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability.
• Identifies revisions, deletions, or additions to the calibration and maintenance programs and Standard Operating Procedures (SOP's) to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures.
• Works with Operations, Technology, Automation, and Quality Approvers to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition.
• Helps establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.
• Leads deviation investigations for instruments, equipment, and system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments.
• Leads the identification and implementation of process improvement projects, productivity initiatives, and corrective actions while focusing on equipment uptime, minimizing cost, and maintaining process consistency.
• Develops training material and provides necessary training for system maintenance as a subject matter expert (SME).
• Collaborates with operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
• Supports safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective.
• Collaborates with production area maintenance technicians and engineers to maintain all production equipment.
• Collaborates with Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area-specific reliability actions.

Requirements

• Bachelor of Science in Engineering with two (2) years of production and/or calibration and/or maintenance background or Master of Science in Engineering.
• Strong planning, scheduling, and time management skills.
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.
• Good oral and written communication skills.
• Qualify and Maintain Grade 'A' gowning.
• Experience with GMP compliant maintenance databases.
• Project management experience including change control and equipment qualification.
• Experience with plant utility systems.
• SAP Knowledge and experience.

Nice-to-haves

• cGMP experience in a sterile, bulk or finished pharmaceutical environment.
• Familiarity with sterilizers of sterilized components.
• Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.
• Experience in automation and manufacturing execution system (MES), process modeling, and process improvement.
• Experience in deviation management, troubleshooting, and resolving manufacturing anomalies.

Benefits

• Health insurance
• Dental insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development opportunities
• Employee discount programs