Senior Mechanical Services Engineer (Utilities)

MSD•Durham, NC

1d•$117,000 - $184,200•Onsite

About The Position

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and be part of a company that is making a difference. The Senior Mechanical Services Engineer position will ensure the reliable performance of equipment by providing 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 (5) years’ experience 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
Adaptability
Change Control Processes
Customer-Oriented
Deviation Management
Engineering Standards
Good Manufacturing Practices (GMP)
Maintenance Engineering
Manufacturing Process Validation
Process Optimization
Regulatory Compliance
Root Cause Analysis (RCA)
Strategic Thinking
Teamwork
Technical Support
Technical Transfer

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
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

Analyze calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability
Identify revisions, deletions, or additions to the calibration and maintenance programs and Standard Operating Procedures (SOPs) to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures
Work with 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
Help establish processes that ensure required Safety guidelines are followed and participate in divisional Safety Audit activities
Lead 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 and work as a subject matter expert (SME) to 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
Collaborate with the production area maintenance technicians and engineers to maintain all production equipment
Collaborate with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area-specific reliability actions