Sterile Automation Engineer (2nd Shift)

HireLifeScience; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Job summary

HireLifeScience is seeking an Automation Engineering Specialist for our Rahway, NJ FLEx Sterile center. You will provide end-to-end automation support for sterile clinical manufacturing, including formulation, filling, lyophilization, and related operations.

The role focuses on validated systems, lifecycle management, data integrity, and cross-functional collaboration to enable scalable, compliant processes.

Qualifications

• Bachelor's degree in an Engineering, Science, IT, or related field.
• Minimum 2 years in process automation or equivalent.
• Strong communication and project management skills.
• Proven performance and teamwork.

Responsibilities

• Maintain automation systems in a validated, compliant state per cGMP and lifecycle best practices.
• Provide end-to-end automation support for sterile clinical manufacturing and process operations.
• Lead changes, investigations, CAPAs; support audits and inspections.
• Develop and execute automation change controls, risk assessments, and regulatory filings.
• Represent automation on capital projects; drive continuous improvement and site-wide standards.
• Coordinate installation, integration, FAT/SAT, commissioning and qualification of new equipment.
• Collaborate with IT, QA, Manufacturing Operations, and vendors to ensure reliability and compliance.
• Supervise contract engineers/vendors and manage workloads and deliverables.

Skills

cGMP knowledge

Data integrity

Root cause analysis

Troubleshooting

Cross-functional teamwork

Technical writing

Python scripting

Education

Bachelor's degree in Engineering/Science/IT

Minimum 2 years automation experience

Tools

PLC/SCADA

iFix

WinCC OA

Ignition

OPC

Industrial networks

Job description

HireLifeScience is seeking an Automation Engineering Specialist for our Rahway, NJ FLEx Sterile center. You will provide end-to-end automation support for sterile clinical manufacturing, including formulation, filling, lyophilization, and related operations.

The role focuses on validated systems, lifecycle management, data integrity, and cross-functional collaboration to enable scalable, compliant processes.