JOB SUMMARY

We are seeking an experienced Senior Automation Engineer to support manufacturing and utilities operations in a regulated pharmaceutical environment. This role will focus on maintaining and optimizing process equipment, implementing automation solutions, and ensuring compliance with cGMP, data integrity, and regulatory requirements. The ideal candidate will have strong technical expertise in process automation, computerized systems validation, and project management within the pharma or biotech sector.

QUALIFICATIONS

• Bachelor’s degree in Electrical, Computer, Mechanical Engineering, or related field.
• Minimum 5 years of experience in pharmaceutical manufacturing or operations, with at least 4 years in process automation and 2 years in computerized systems validation.
• Strong knowledge of computer system lifecycle, change control, and FDA regulatory requirements.
• Hands-on experience with Rockwell Automation, Siemens, Wonderware, or similar platforms.
• Proficiency with PLC programming, SCADA, MES, databases (MS SQL), and networking infrastructure.
• Experience with data historian tools (OSI PI or equivalent).
• Ability to read and interpret electrical and mechanical drawings.
• Strong problem-solving, project management, and communication skills.
• Bilingual English/Spanish required.

PREFERRED SKILLS

• Experience with CMMS systems (e.g., Maximo).
• High degree Knowledge and experience in Rockwell Automation Platforms
• Knowledge and experience in Siemens systems.
• Knowledge of FactoryTalk Batch, MES Syncade, VMWare vSphere, and OSI Soft AVEVA PI.
  You’ll be part of a collaborative, high-performance team working at the forefront of pharmaceutical automation, with opportunities to contribute to critical projects that enhance manufacturing efficiency, compliance, and innovation.

• Ensure reliable operation of manufacturing and utilities process equipment, including programming, troubleshooting, and preventive maintenance.
• Provide technical support for installation, configuration, integration, qualification, and upgrades of automated and computerized systems (PLCs, HMIs, SCADA, DCS/BAS, MES, databases, networking).
• Develop and implement software/hardware changes to improve processes using advanced automation technologies.
• Collaborate with cross-functional teams (Manufacturing, Quality, IT, Engineering) to deliver automation projects and operational support.
• Review, test, and validate automation software and hardware to meet operational and compliance requirements.
• Participate in Computer System Validation (CSV) activities, ensuring compliance with 21 CFR Part 11, cGMP, and data integrity standards.
• Support audits, quality events, CAPA, and change control processes for automated systems.
• Develop and maintain automation-related procedures, including maintenance, security, backup/restoration, and disaster recovery.
• Contribute to process automation strategy, standards, and technology upgrades.