Specialist, Engineering; Onsite

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile 2 facility expansion is a strategic capital project designed to significantly enhance clinical supply manufacturing capacity by adding a second sterile filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities.

The Durham, North Carolina site is a commercial vaccine manufacturing facility with drug substance, drug product, and sterile supply manufacturing operations, and supporting infrastructure and utilities.

The 12 to 18 month rotation at the Durham, NC site will allow the Specialist Engineer to gain experience supporting commercial drug product manufacturing operations including formulation, filling, lyophilization, and visual inspection. Responsibilities at the Durham site will be based on business needs and may include but are not limited to shop floor equipment and automation troubleshooting, deviation investigation support, change controls, equipment validation, technical protocol authoring and execution, and equipment maintenance.

FLEx 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, and supporting utility suites. These roles provide technical support across formulation, process development, manufacturing, equipment, and automation to ensure GMP compliance, operational readiness, and efficient, reliable sterile drug product operations.

• Serve as technical SME for formulation, process development, and scale-up activities.
• Support manufacturing by authoring quality investigations, change controls, SOPs, and technical protocols required to support clinical drug product operations.
• Contribute the execution of the commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
• Collaborate closely with the formulation scientists, engineers, 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.
• Work with a variety of state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment while completing processes throughout the manufacturing cycle
• Manage individual project assignments and aid in facility and process equipment innovation.
• Perform manual and/or automated operations, general maintenance, troubleshooting and support functions

• Serve as a technical SME for equipment troubleshooting, maintenance, and coordination with engineering, utilities, facilities, OEM vendors, and contractors.
• Support Quality Engineering and capital projects, including equipment installation, commissioning, validation, and lifecycle management.
• Lead sterilization and cleaning validation programs by authoring and reviewing validation documents, coordinating execution activities, conducting technical assessments, and supporting regulatory inspections as a validation SME.
• Own change management, periodic reviews, deviation investigations, root cause analyses, and CAPA implementation while maintaining GMP documentation.
• Maintain GMP-compliant facilities, utilities, and manufacturing equipment using reliability maintenance practices, tracking calibrations and PMs, and assisting with shutdown planning and execution.
• Manage operational and administrative activities including work order oversight, contractor coordination, purchase orders, budgets, asset tracking, and project closeout activities.

• Maintain validated and compliant automation systems for sterile manufacturing, ensuring adherence to GMP, data integrity, cybersecurity, and lifecycle management requirements.
• Provide automation support for formulation, filling, and lyophilization operations, including troubleshooting, root cause analysis, reliability improvements, and on-floor manufacturing support.
• Lead automation change management, investigations, CAPAs, periodic reviews, and regulatory inspection readiness while maintaining automation documentation and system configurations.
• Support capital projects and new product introductions by leading automation…