Process Engineer, Sterile And Liquids Pilot Plant

Process Engineer

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. 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.

Qualifications:

Education Minimum Requirement:

• Required: 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)

Required Experience and Skills:

• 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.

Preferred Experience and skills:

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

Location: West Point, PA and Rahway, NJ

Required Skills:

Biological Sciences, cGMP Guidelines, Chemical Engineering, Clinical Programs, GMP Compliance, Laboratory Experiments, Operations Support, Pilot Plant Operations, Process Engineering, Process Improvement Projects, Process Optimization, Product Formulation, Project Manufacturing, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Technical Writing, Troubleshooting

Preferred Skills:

Salary range for this role is $87,300.00 - $137,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.