Sterile Liquids Process Engineer for Clinical Development

Merck; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. at West Point, PA seeks a Process Engineer to provide technical input on sterile processes, oversee manufacturing projects, and ensure GMP-compliant delivery of clinical and development batches. The role interfaces with development scientists and drives deviation management and process improvements.

The position requires a BS in a scientific field, 3+ years in a technical/ops role, and strong cross-functional leadership, with a focus on sterile manufacturing and documentation.

Qualifications

• 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

Responsibilities

• Interface with development scientists for sterile batch manufacturing.
• Oversee deviation management and process improvement projects.
• Implement new technologies and lead process design.
• Provide GMP expertise to ensure timely supply of clinical and development batches.

Skills

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

GMP

Manufacturing

Manufacturing Processes

Problem Identification

Process Design

Process Development (PD)

Process Engineering

Process Hazard Analysis (PHA)

Process Optimization

Education

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

Job description

Merck & Co., Inc. at West Point, PA seeks a Process Engineer to provide technical input on sterile processes, oversee manufacturing projects, and ensure GMP-compliant delivery of clinical and development batches. The role interfaces with development scientists and drives deviation management and process improvements.

The position requires a BS in a scientific field, 3+ years in a technical/ops role, and strong cross-functional leadership, with a focus on sterile manufacturing and documentation.