disability | Principal Engineer, MS&T in Lincolnton, NC

Principal Engineer, MS&T

  • CSL LIMITED
  • $85,980.00 - 124,520.00 / Year *
  • 1120 N Aspen St
  • Lincolnton, NC 28092
  • Full-Time



WARNING:Your JavaScript is disabled. This site does not work without JavaScript. Please enable JavaScript to use all features. The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Fill-Finish Operations.The MS&T function provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements within Formulation, Filling, Inspection, Labelling, and Packaging. Provide front line support of production and process-specific issues. Main Responsibilities: Provide support to manufacturing as the primary point of contact for technical and operational equipment/process issues. Troubleshoot and investigate equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making. Provide ownership of manufacturing documentation (procedures, batch records, training materials, specifications, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related CAPAs. Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity. Identify and implement continuous improvement projects to improve yield, reliability, process robustness, and safety. Provide leadership within assigned area or suite. Lead weekly team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged. Lead after action review sessions and provide recommendations for improvement projects based on key performance indicators and observed trends. Assist with investigations related to product and process including complaints, out of expectation, out of specification, etc. Enroll new materials, revise existing materials, and update bills of materials. Coordinate with vendors for material enrollments and third party complaints. Interface with maintenance, metrology, engineering, and quality to implement and update preventative maintenance plans, coordinate creation and execution of work orders, and ensure spare part quantities are appropriate. Periodic responsibilities include: ensure protocols are executed as intended; support execution of process validations and annual monitoring of batches; liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution Minimum Requirements Bachelor's degree required. Degree in an engineering or science discipline preferred. Minimum 10 years related industry experience required, including 7+ years' experience in pharmaceutical/biotech operations in a technical role. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred. Incumbent must possess an advanced understanding of engineering, equipment, and automation principles and the ability to apply knowledge. An advanced mechanical aptitude or knowledge of electronic / mechanical equipment is required. Proven experience with attention to detail in order to solve a range of routine and non-routine problems. Incumbent must have good organization, presentation, and time management skills. Aktie: Bundesstaat/ProvinzNorth Carolina StadtHolly Springs Hausanschrift475 Green Oaks Pkwy Primary LocationSeqirus USA - NC - Holly Springs Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.
Associated topics: aerodynamic, automotive, brakes, machine, mechanical, motor, powertrain, propulsion, turbine, turbomachinery


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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