Specialist, Automation Engineering - 2nd Shift (Onsite)

Merck; Rahway (NJ); On-site; USD 90,000 - 140,000; Full time

Job summary

Merck in Rahway, NJ seeks a Specialist, Automation Engineering to support sterile clinical manufacturing and capital projects. The role focuses on end-to-end automation for formulation, filling, lyophilization, and related OT/IT systems, ensuring cGMP compliance and data integrity in a start-up facility.

The position may require off-shift or extended hours to support manufacturing operations, and reports to the automation lead within PSCS Pharm Ops Engineering on site.

Qualifications

• Experience in automation engineering within a validated pharmaceutical environment.
• Familiarity with cGMP, data integrity and lifecycle management practices.
• Ability to troubleshoot automation systems on the floor and support OT/IT platforms.

Responsibilities

• Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle practices.
• Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting and performance improvements.
• Implement and sustain platform automation.

Skills

Automation engineering

Process automation

Data integrity

Cybersecurity

Root cause analysis

Job description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start-up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The facility supports the formulation and filling of clinical and developmental sterile products for critical program needs, such as new products in process development, products undergoing scale-up, launch and transfer to the supply network, and existing commercial products undergoing process optimization. Support encompasses both start-up operations (FLEx Sterile1) and a new capital expansion (FLEx Sterile2).
The Specialist, Automation Engineering – role will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures the reliable and compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and associated support activities for clinical and development sterile products. This position supports start-up operations and new capital investments in the clinical supply area, including automation lifecycle management, data and analytics, and site representation on capital projects. Off-shift (second shift and weekend) or extended shift work will be required on an intermittent basis to support manufacturing operations. This role will be an onsite automation support role and directly reports to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead.

Primary Responsibilities

• Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)
• Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements
• Implement and sustain platform automation