Specialist, Engineering

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Specialist, Engineering, will be responsible for support of production of live virus vaccines within bulk vaccine production and/or final formulation and filling operations. This engineer will be a member of the Technical Operations Deviation Management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be leading investigations associated with manufacturing deviations and development of actions in response to these deviations. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/ equipment actions, and other related duties. This position will require development of technical expertise of corresponding IPT operations. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Responsibilities include: Leads and/or works as part of a team on manufacturing investigations, identifying root cause, assessing impact, and recommending corrective actions. Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause. Assures consistent application of standardized work, engineering, project management and process tools. Provides technical support to manufacturing shop floor for problems and issues. Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

Requirements

B.S. degree in Engineering or Sciences.
Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).
Demonstrated ability to drive results
Strong communication, collaboration skills and ability to drive accountability
Strong problem-solving skillset
Change Control Management
Corrective Action Management
Good Manufacturing Practices (GMP)
Manufacturing
Manufacturing Operations
Process Optimization
Root Cause Analysis (RCA)

Nice To Haves

Vaccine manufacturing
Sterile processing
Experience authoring investigations

Responsibilities

Leads and/or works as part of a team on manufacturing investigations, identifying root cause, assessing impact, and recommending corrective actions.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Assures consistent application of standardized work, engineering, project management and process tools.
Provides technical support to manufacturing shop floor for problems and issues.
Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.