Senior Manufacturing Automation Engineer - Biopharma GMP

MSD; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Job summary

MSD in West Point, PA seeks a Senior Specialist Manufacturing Automation Engineer to own process automation across Barrier Operations Formulation and Filling. You will troubleshoot, maintain cGMP-compliant automation, and act as SME within a production team, driving improvements and supporting audits.

The role requires a BS in engineering or CS and 5+ years in a regulated automation role, with strong matrix leadership, PLC/DCS experience, SDLC, and excellent communication.

Qualifications

• BS in Engineering, Computer Science or related field.
• Minimum of five (5) years of experience in a manufacturing automation-related role in a regulated industry.
• Ability to translate manufacturing requirements into automation/digital solutions.
• Strong analytical, problem-solving, and attention to detail.
• Strong written and verbal communication.
• Leadership in a matrix organization.
• System validation and other quality management functions.
• Experience with SDLC and change controls for GMP regulated processes/systems.

Responsibilities

• Troubleshoot challenging equipment/automation issues and drive improvements.
• Maintain automation systems in compliance with cGMP through equipment life cycle.
• Act as automation SME within a production team and provide technical assistance.
• Support peers in areas of expertise for team success.
• Review automation documents, preventive maintenance, and SOPs for GMP/safety compliance.
• Develop and support corrective actions for investigations related to automation/IT systems.
• Ensure efficient operation of automated processing and IT systems.
• Participate in audits and training; provide floor support.
• Generate and implement change controls to meet facility needs.

Skills

cGMP Guidelines

cGMP Regulations

DCS Configuration

Industrial Communication Protocols

Investigation Management

IQ OQ PQ

IT Systems Integration

Matrix Leadership

Matrix Management

Programmable Logic Controller (PLC)

SDLC

Technical Project Management

Technical Writing

Troubleshooting

Education

BS in Engineering, Computer Science or related field

Tools

DeltaV DCS

Allen-Bradley PLC

OPC

Siemens Step7

Modbus/Fieldbus/Profibus

Virtual Machines

Database management

IT administration

Job description

MSD in West Point, PA seeks a Senior Specialist Manufacturing Automation Engineer to own process automation across Barrier Operations Formulation and Filling. You will troubleshoot, maintain cGMP-compliant automation, and act as SME within a production team, driving improvements and supporting audits.

The role requires a BS in engineering or CS and 5+ years in a regulated automation role, with strong matrix leadership, PLC/DCS experience, SDLC, and excellent communication.