Automation Engineer

Responsibilities

• Administer and manage site automation systems including SCADA, PLCs, and computerized QC Lab instruments
• Develop and execute Validation Protocols, Reports, and Lifecycle documents
• Create and improve Administration SOPs for automation systems
• Monitor integrity, availability, performance, and operability of automation systems
• Identify, investigate, and correct technical issues using root cause analysis
• Manage user access and ensure compliance with regulatory standards
• Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT)
• Author Change Controls and Test Scripts

Requirements

• Bachelor of Science in Electrical Engineering, Computer Science, IT, or related field
• 5-7 years of related experience in automation systems operation and validation for biologics
• Proven experience as an IT Automation Engineer or similar role
• Direct knowledge of biologics process equipment, SCADA/control systems, and IT networking
• Expertise in Equipment Qualification and Computer System Validation
• Knowledge of FDA, ICH, USP, and EMEA guidelines (21 CFR Part 11, GAMP 5)
• Proficiency in SAP, Veeva Vault, and Maximo

Preferred Qualifications

• Expertise in Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra, DeltaV, or Vaisala ViewLinc
• Experience with Repligen and Thermo Scientific instruments

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with company match
• Paid parental leave
• Paid time off including vacation, personal, and sick time
• Flexible spending and health savings accounts
• Commuter benefits and well-being initiatives

About the Company

GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products.