Mechanical Services Engineer 2nd shift

Job Description

The Mechanical Services Engineer position will ensure the reliable performance of equipment by providing handson 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 selfidentify 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 (SOPs) 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 wellinvestigated and welldocumented 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 teams objectives vision and goals. This position could be used to support any of the manufacturing facilities on the Durham site.

Education:

• Bachelor of Science in Engineering with two 2 years of production and/or calibration and/or maintenance background

Or

• Master of Science in Engineering

Experience and Skills:

Required:

• Good 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.

• 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 problemsolving 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.

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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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