Mechanical Services Engineer

Job Description

The Mechanical Services Engineer is a member of the Engineering and Maintenance team providing technical support within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

The 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 Mechanical Services Engineer must be able to self-identify opportunities for improvement and execute with minimal supervision.

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

• 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 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.  This position could be used to support any of the manufacturing facilities on the Durham site.

Education:

• Associates Degree with two (2) years of production and/or calibration and/or maintenance background 

Or

• Bachelor of Science in Engineering

Required Experience and Skills:

• 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 maintenance databases

• Project management experience including change control and equipment qualification 

• Experience with plant utility systems

• SAP Knowledge, experience

Preferred Experience and Skills:

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

• Experience with automated drug product filling, lyophilization, and inspection equipment.

• 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

NOTICE FOR INTERNAL APPLICANTS

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