Senior Specialist Engineering, Sterile/Liquids (Onsite)

Job Description

Description – Sr. Specialist, Engineering

The Sterile/Liquids Pilot Plants (SLP,) located in Bldg. 17 at West Point, is part of the Pharmaceutical Sciences organization.  The SLP supports the formulation and filling of clinical, stability, and developmental supplies for vaccines, small molecules, and therapeutic proteins.  The SLP interfaces with a large network including multiple of our Company's Research Laboratories teams, Sterile/Liquids Commercialization (SLC), commercial supply, and other pilot plants within the PharmSci network.  SLP supplies support critical program needs related to new products undergoing process development, new products undergoing scale-up, launch, and transfer to the supply network, and existing commercial products undergoing process optimization.

The Process Engineer (PE) provides technical input on sterile processes from a facility and operational standpoint, provides manufacturing project management oversight, and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements.  This person is the main interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP.  Additional responsibilities include deviation management, process improvement projects, implementation of new technologies, and process design.

Qualifications:

Education Minimum Requirement:

• Required:  Bachelor's of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field    

Required Experience and Skills:

• Minimum of 3 years in a technical or operations support role

• Sterile process manufacturing and/or formulation development

• Knowledge of manufacturing equipment and Good Manufacturing Practices

• Project management 

• Analytical problem-solving skills

• Cross functional leadership

• Technical writing – including batch documentation, investigations, protocols

Location:

• West Point, PA

eligibleforERP

Required Skills:

Adaptability, Adaptability, Analytical Testing, Batch Production Records, Biologics, Chemical Engineering, Chemistry, Clinical Manufacturing, Cross-Functional Project Management, Data Analysis, Detail-Oriented, Deviation Management, Documentation Preparation, Drug Formulations, Equipment Qualification, Functional Management, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Processes, Problem Identification, Process Design, Process Development (PD), Process Engineering, Process Hazard Analysis (PHA), Process Optimization {+ 7 more}

Preferred Skills:

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