Sr. Specialist Engineer (PIE)

MSD•Wilson, NC

29d•$117,000 - $184,200•Hybrid

About The Position

Position Overview – Essential Functions Essential Functions include, but are not limited to: The Senior 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 Primary Activities include, but are not limited to: Lead teams to identify, prioritize, and implement improvements related to Safety, People, Quality, Delivery, and Cost via detailed analysis of operating performance trends. Implementation of new technology (i.e. procedures for new packaging equipment, electronic batch records, etc.) Collaborate independently with Engineering Change Management personnel to facilitate execution. Lead structured problem solving and implement corrective actions to prevent reoccurrence. Author complex deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs). Tracks and trends operating performance (metrics) and works cross-functionally to drive required actions. Manage complex projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhancement of compliance and safety. Implement and optimize standardized work (i.e. Tier meetings, task breakdown sheets, etc.) within the Operations department.

Requirements

BS Degree in an engineering discipline or equivalent/comparable/applicable BS Degree
Minimum of 5 years of relevant industrial experience
Demonstrated ability to work independently
Demonstrated leadership, communication (written and verbal), collaboration, project management and data analysis skills
Demonstrated experience in identification and implementation of process optimization solutions.
Demonstrated formal problem-solving e.g. root cause analysis, fishbone, 5 whys, and/or other Lean Six Sigma tools
Experience writing technical documents including documentation supporting standard operating procedures, batch records, investigations, change controls, and documentation of scientific data
Experience with data analysis software (i.e. Excel, Minitab, JMP, etc.)

Nice To Haves

Minimum of 2 years of vaccine/pharmaceutical experience
Experience in a pharmaceutical packaging environment
Formal training in Lean and/or Six Sigma methodologies
Experience with SAP

Responsibilities

Lead teams to identify, prioritize, and implement improvements related to Safety, People, Quality, Delivery, and Cost via detailed analysis of operating performance trends.
Implementation of new technology (i.e. procedures for new packaging equipment, electronic batch records, etc.)
Collaborate independently with Engineering Change Management personnel to facilitate execution.
Lead structured problem solving and implement corrective actions to prevent reoccurrence.
Author complex deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs).
Tracks and trends operating performance (metrics) and works cross-functionally to drive required actions.
Manage complex projects across the Operations area related to changes supporting increased reliability, demonstration of new technology, or enhancement of compliance and safety.
Implement and optimize standardized work (i.e. Tier meetings, task breakdown sheets, etc.) within the Operations department.