Specialist, Engineering

MerckWilson, NC
Hybrid

About The Position

The Specialist, Engineering will provide support for packaging operations in a range of capacities including: analysis of operating performance, management of key operational data within SAP, application of advanced problem-solving capabilities, strengthening compliance posture and inspection readiness, and investigating and authoring deviations related to unplanned events. Primary activities include leading teams to identify, prioritize, and implement improvements related to Safety, People, Quality, Delivery, and Cost via detailed analysis of operating performance trends. This role involves leading structured problem solving (i.e. 5 Whys, Fishbones, etc.) and implementing corrective actions to prevent reoccurrence. It also includes the implementation of new technology (i.e. installation of new packaging equipment, electronic batch records, etc.) and managing small scale projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhancement of compliance and safety. The Specialist will also author deviations and work to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs), and implement and optimize standardized work (i.e. Tier meetings, task breakdown sheets, etc.) within the Operations department.

Requirements

  • BS Degree in Engineering, Industry Technology
  • Minimum of 2 years of relevant industrial experience
  • Demonstrated ability to work independently
  • Demonstrated communication (written and verbal), collaboration, project management and data analysis skills
  • Technical writing experience i.e. documentation of scientific data.
  • Demonstrated experience in identification and implementation of process optimization solutions.
  • Demonstrated formal problem-solving e.g. fishbone, 5 whys.

Nice To Haves

  • Working knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry.
  • Formal training in Lean and/or Six Sigma methodologies
  • Experience writing technical investigations, change controls, operating procedures, and batch records
  • Experience with SAP
  • Experience with data analysis software (i.e. Excel, Minitab, JMP, etc.)
  • Project management

Responsibilities

  • Lead teams to identify, prioritize, and implement improvements related to Safety, People, Quality, Delivery, and Cost via detailed analysis of operating performance trends.
  • Lead structured problem solving (i.e. 5 Whys, Fishbones, etc.) and implement corrective actions to prevent reoccurrence.
  • Implement of new technology (i.e. installation of new packaging equipment, electronic batch records, etc.).
  • Manage small scale projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhancement of compliance and safety.
  • Authors deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs).
  • Implement and optimize standardized work (i.e. Tier meetings, task breakdown sheets, etc.) within the Operations department.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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