Process Engineer, Sterile/Liquids Pilot Plant

MSD•Upper Gwynedd Township, PA

3d•Hybrid

About The Position

Description – Process Engineer The Sterile/Liquids Pilot Plants (SLP) is located in Bldg. 17 at West Point, PA and is part of the Pharmaceutical Sciences and Device Development (PSDD) 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 Research & Development Division teams, Sterile Drug Product Commercialization (SDPC), commercial supply, and other pilot plants within the PSDD network. The SLP supports 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 SLP Process Engineer (PE) provides technical input on sterile processes from a facility and operational standpoint, manufacturing project management oversight, and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements. The PE is the main interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP. PE responsibilities include monitoring the achievement of batch planning and execution progress compared to program timelines with sub-teams and key support functions. The PE will perform key batch activities, such as authoring the batch record, coordinating transfer and receipt of batch inputs, providing shopfloor support during batch manufacture, and sample & batch delivery. In this role, the PE is expected to leverage their relationships and networks to improve and enhance team dynamics, with guidance from senior team members and leads as needed. The engineer should proactively identify and escalate potential obstacles to drive business results. The engineer prepares and facilitates key team meetings including creating agendas, ensuring appropriate participation, contributing program management insights, and following up to ensure the team continues to make progress towards deliverables. The PE participates in department initiatives and workstreams aimed at improving the way that we work and interact with one another. The PE will utilize their technical subject matter expertise, leverage departmental procedures, and adhere to quality and compliance requirements to execute on batch manufacturing. The PE will own relevant change control and lead deviations, inclusive of impact assessment, root cause analysis, and CAPA identification. Additional responsibilities include the implementation of new technologies and support of process improvement projects.

Requirements

Bachelors of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field
Minimum of 1.5 years in a technical or operations support role
Knowledge of manufacturing equipment and Good Manufacturing Practices
Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project initiative status and issues at the right level of detail.
Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.
Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.
Demonstrated ability to generate innovative solutions to complex problems and effectively work with and communicate to key stakeholders.
Adaptability
cGMP Guidelines
Personal Initiative
Process Engineering
Process Optimization
Product Formulation
Standard Operating Procedure (SOP) Writing
Sterile Manufacturing
Teamwork
Technical Writing
Troubleshooting

Nice To Haves

Sterile process manufacturing and/or formulation development
Project management
Cross functional leadership
Change Control
Deviation Management
Strong technical writing
Electronic Batch Records
Laboratory Research
Pilot Plant Operations

Responsibilities

Provide technical input on sterile processes from a facility and operational standpoint
Manufacturing project management oversight
GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements
Main interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP
Monitoring the achievement of batch planning and execution progress compared to program timelines with sub-teams and key support functions
Authoring the batch record
Coordinating transfer and receipt of batch inputs
Providing shopfloor support during batch manufacture, and sample & batch delivery
Leverage relationships and networks to improve and enhance team dynamics
Proactively identify and escalate potential obstacles to drive business results
Prepares and facilitates key team meetings including creating agendas, ensuring appropriate participation, contributing program management insights, and following up to ensure the team continues to make progress towards deliverables
Participates in department initiatives and workstreams aimed at improving the way that we work and interact with one another
Own relevant change control and lead deviations, inclusive of impact assessment, root cause analysis, and CAPA identification
Implementation of new technologies and support of process improvement projects.