Process Engineer, Sterile and Liquids Pilot Plant

Merck•Upper Gwynedd Township, PA

3d•$87,300 - $137,400•Onsite

About The Position

The Sterile and Liquids Pilot Plant (SLP) and the Formulation, Laboratory, and Experimentation (FLEx) Center are clinical supply manufacturing facilities within the Pharmaceutical Sciences and Device Development (PSDD) organization. The Process Engineer (PE) position will initially be based in West Point, PA for approximately 18 to 24 months to support business needs. After completion of this initial 18-to-24-month period, the role will relocate to Rahway, NJ based on business needs. SLP and FLEx support the formulation and filling of clinical, stability, and developmental supplies for vaccines, biologics, and small molecules. The PE will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of the company's pipeline. The 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. 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. The role will require on site support.

Requirements

Bachelors Degree (Preferred: degree in Chemical Engineering, Chemistry, Biology or related Scientific Field) or Bachelors Degree anticipated by June-2026 (would require confirmation of degree prior to start date)
Minimum of 1.5 years in research, 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 teams and networks; able to foster cooperation in others, using the 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.
Valid Driving License: Yes

Nice To Haves

Project management
Cross functional leadership
Change Control
Deviation Management
Strong technical writing
Sterile process manufacturing and/or formulation development

Responsibilities

Provides 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.
Main interface with development scientists for manufacturing of sterile liquid clinical and development batches.
Monitoring the achievement of batch planning and execution progress compared to program timelines.
Authoring the batch record.
Coordinating transfer and receipt of batch inputs.
Providing shopfloor support during batch manufacture.
Sample & batch delivery.
Leverage relationships and networks to improve and enhance team dynamics.
Proactively identify and escalate potential obstacles.
Prepare and facilitate key team meetings.
Participate in department initiatives and workstreams.
Utilize technical subject matter expertise, leverage departmental procedures, and adhere to quality and compliance requirements.
Own relevant change control and lead deviations, inclusive of impact assessment, root cause analysis, and CAPA identification.
Implementation of new technologies.
Support of process improvement projects.