Sr. Spclst, Engineering

Job Description

P3 Senior Mechanical Services Engineer Job Description

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.

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.

This position is a 2nd 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.  This position could be used to support any of the manufacturing facilities on the Durham site.

Education:

     Required:

• Bachelor of Science in Engineering with six (6) years of production and/or calibration and/or maintenance background 

Or

• Master of Science in Engineering with four (4) years of production and/or calibration and/or maintenance background 

Required:

• 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

• Qualify and Maintain Grade” A” gowning.

• Experience with GMP compliant maintenance databases

• Project management experience including change control and equipment qualification.

Preferred:

• cGMP experience in a sterile, bulk or finished pharmaceutical environment.

• Experience with Clean Utilities, to include Reverse Osmosis systems, WFI generation and distribution.

• 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, process modeling and process improvement

• Experience with deviation management, troubleshooting and resolving manufacturing anomalies. #EBRG VetJobs

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