Process Engineer, Sterile and Liquids Pilot Plant

MSD • Upper Gwynedd Township, PA

3d • $87,300 - $137,400 • Onsite

About The Position

The Sterile and Liquids Pilot Plant (SLP) in West Point, PA and the Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, NJ 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. This location change will not be considered as “termination of employment due to a restructuring” as defined in our Company's US Employee Separation Benefit Plan. 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 our 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.

Requirements

• 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.
• 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)
• Valid Driving License

Nice To Haves

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

Responsibilities

• Monitoring the achievement of batch planning and execution progress compared to program timelines with sub-teams and key support functions.
• Performing 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.
• Leveraging relationships and networks to improve and enhance team dynamics, with guidance from senior team members and leads as needed.
• Proactively identifying and escalating potential obstacles to drive business results.
• Preparing and facilitating 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.
• Participating in department initiatives and workstreams aimed at improving the way that we work and interact with one another.
• Utilizing technical subject matter expertise, leveraging departmental procedures, and adhering to quality and compliance requirements to execute on batch manufacturing.
• Owning relevant change control and leading deviations, inclusive of impact assessment, root cause analysis, and CAPA identification.
• Implementing new technologies and supporting process improvement projects.
• Providing technical input on sterile processes from a facility and operational standpoint.
• Providing manufacturing project management oversight.
• Providing GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level