Merck
Calibration Engineer Sr. Specialist
Merck - Durham, North Carolina, United States, 27701
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Overview
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Overview
Sr. Specialist, Calibration Engineer
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The Sr. Specialist, Calibration Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham Bulk Facility. The successful candidate will provide calibration, instrumentation and controls support for Clean Utilities, Purification, Sterile Supply, Alum and Fermentation suites. This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into atypical instrument events and continuous improvement by through analysis of instrument performance. General Profile: Individual contributor role working with calibration teams across the site with limited oversight to focus instrument performance and minimize downtime. Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality notifications follow when required. Facilitate scheduling of calibration activities with the Planning and Scheduling team. Anticipates and interprets client and/or customer needs to identify solutions. Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners. Initiate, Review or Approve changes in the Calibration system (ProCal). Manage approved vendors for calibrations not performed by site personnel. Participate in site shutdown meetings, ensuring calibration activities are tracked to completion. Participate in RBAM updates for the whole site. Establish Metrics to monitor performance of instruments and be able to identify trends. Work with project personnel to ensure appropriate instrument turnover to site. Expand knowledge into other systems, capable of managing change in the pursuit of continuous improvement. Lead projects for a B150 Engineering/Maintenance. SME on Instrumentation and control loops, i.e., 4 to 20 mA, HART, ASI and Profibus communication Able to train individuals in the execution of calibration work for the site. Capable technical writing skills, able to document assessments used to justify changes to instrumentation. The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause. 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. Required Education, Experience and Skills: Bachelor's Degree or higher in Engineering, Science or related field. 4 years of experience in field calibration, metrology or equipment reliability. Project Management experience Familiarity of regulatory requirements in accordance with GMP manufacturing operations Good oral and written communication skills Experience with GMP compliant calibration databases Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools. Technical writing and deviation investigation experience Experience in problem solving and troubleshooting. Preferred Education, Experience and Skills: Project Management experience Familiarity of "World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) ProCal or similar digital calibration system experience. Allen Bradley PLC and Delta V controls experience VFD Troubleshooting Familiar with data analysis tools to analyze large amounts of data (ex. PowerApps, Spotfire) cGMP experience in a sterile, bulk or finished pharmaceutical environment. Mechanical functionality and reliability knowledge (asset management) Certified Maintenance Professional (CMRP, CRL, etc.) Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The Sr. Specialist, Calibration Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham Bulk Facility. The successful candidate will provide calibration, instrumentation and controls support for Clean Utilities, Purification, Sterile Supply, Alum and Fermentation suites. This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into atypical instrument events and continuous improvement by through analysis of instrument performance. General Profile: Individual contributor role working with calibration teams across the site with limited oversight to focus instrument performance and minimize downtime. Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality notifications follow when required. Facilitate scheduling of calibration activities with the Planning and Scheduling team. Anticipates and interprets client and/or customer needs to identify solutions. Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners. Initiate, Review or Approve changes in the Calibration system (ProCal). Manage approved vendors for calibrations not performed by site personnel. Participate in site shutdown meetings, ensuring calibration activities are tracked to completion. Participate in RBAM updates for the whole site. Establish Metrics to monitor performance of instruments and be able to identify trends. Work with project personnel to ensure appropriate instrument turnover to site. Expand knowledge into other systems, capable of managing change in the pursuit of continuous improvement. Lead projects for a B150 Engineering/Maintenance. SME on Instrumentation and control loops, i.e., 4 to 20 mA, HART, ASI and Profibus communication Able to train individuals in the execution of calibration work for the site. Capable technical writing skills, able to document assessments used to justify changes to instrumentation. The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause. 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. Required Education, Experience and Skills: Bachelor's Degree or higher in Engineering, Science or related field. 4 years of experience in field calibration, metrology or equipment reliability. Project Management experience Familiarity of regulatory requirements in accordance with GMP manufacturing operations Good oral and written communication skills Experience with GMP compliant calibration databases Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools. Technical writing and deviation investigation experience Experience in problem solving and troubleshooting. Preferred Education, Experience and Skills: Project Management experience Familiarity of "World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) ProCal or similar digital calibration system experience. Allen Bradley PLC and Delta V controls experience VFD Troubleshooting Familiar with data analysis tools to analyze large amounts of data (ex. PowerApps, Spotfire) cGMP experience in a sterile, bulk or finished pharmaceutical environment. Mechanical functionality and reliability knowledge (asset management) Certified Maintenance Professional (CMRP, CRL, etc.) Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.