Sr. Spclst, Engineering - 2nd Shift

Merck & Co. • Eno Valley, NC

200d • $114,700 - $180,500 • Onsite

About The Position

The Senior Mechanical Services Engineer position will ensure the reliable performance of equipment during by provide hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior Mechanical Services Engineer must be able to self-identify opportunities for improvement and execute with minimal supervision.

Requirements

• Bachelor's Degree or higher in Engineering, Science or related field
• Minimum of five years' in a production and/or calibration and/or maintenance background
• Strong planning, scheduling, and time management skills
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Good oral and written communication skills
• Experience with GMP compliant calibration and maintenance databases
• Project management experience including change control and equipment qualification

Nice To Haves

• cGMP experience in a sterile, bulk or finished pharmaceutical environment
• 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
• Experience with Lyophilization and/or Filling Manufacturing Processes and equipment

Responsibilities

• Analyzes calibration, maintenance, and equipment 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
• Work with the Operations, Technology, Automation, and Quality Approvers to determine the breadth and scope of the investigation 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
• Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
• Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance
• Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements
• Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective
• Collaborates with the production area maintenance technicians and engineers to maintain all production equipment
• Collaborates with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area specific reliability actions

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree