Senior Mechanical Services Engineer; Utilities

Job Description

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.

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This position is a 1st shift position with the potential for infrequent off shift work as needed to support business results.

- This position is expected to work as an independent member of an integrated team focused on achieving the team's objectives, vision, and goals-

• 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, HEP, 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

Required

• 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

Preferred

• 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

Required Skills: 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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin,…