Automation & Computerized Systems Engineer (Pharma)

Type: Contract 
Schedule: Monday–Friday

Overview

We’re looking for an experienced Automation & Computerized Systems Engineer to support day-to-day operations and capital projects across Manufacturing and Utilities. You’ll keep process equipment running, lead/execute software-hardware changes, and drive compliance  for new and existing systems such as PLCs, HMIs, DeltaV, FactoryTalk, SCADA, DCS/BAS, MES, OSI PI, and related networks.

What You’ll Do

• Ensure continuous operation of process equipment, including programming, configuration, and preventive/corrective maintenance for Manufacturing and Utilities areas.

• Provide technical support during installation, integration, troubleshooting, qualification, and upgrades of computerized/automation systems (PLCs, HMI/SCADA/DCS/BAS, report engines, databases, printers, comms interfaces, MES).

• Execute software/hardware changes using sound SDLC/CSV practices; recommend process improvements using state-of-the-art automation technologies.

• Participate as a core team member on implementation projects; advise on best use of technology and automation standards.

• Install, configure, test, and maintain control systems; develop interfaces and reports (incl. 4GL tools when needed).

• Train end-users and provide ongoing application support in line with established procedures.

• Review and test programs to meet vendor and site requirements; adjust configurations to verify expected functionality prior to release.

• Review and evaluate proposed design changes to align with cGMP, data integrity, and site standards.

• Execute and close change controls; maintain validated state and documentation.

• Support deviations, CAPA, audits, and standalone quality/reliability actions for MFG/Engineering/Lab systems and MES applications.

• Track project status against plans/milestones; surface risks and propose mitigations to meet due dates.

• Help define/maintain site standards for software automation, system integration, and minimum requirements for plant automation.

• Author/review procedures: Operations, Maintenance, Security, Backup/Restore, Disaster Recovery.

• Coordinate with vendors; implement recommendations/patches per change control.

• Support Data Integrity and Cybersecurity initiatives and Computer System Validation (CSV) activities.

• Stay current with emerging automation technologies and best practices.

Requirements

• BS in Electrical, Computer, Mechanical Engineering or related field.

• 5+ years in pharmaceutical operations or manufacturing; ≥4 years in process automation and ≥2 years in computerized systems validation (CSV) within pharma.

• Strong knowledge of cGMP, 21 CFR Part 11, SDLC, change control, and computer system lifecycle.

• Proven experience preparing User/Functional Requirements (URS/FRS) and Design Specs (DS).

• Hands-on with PLC/SCADA/DCS design, installation, commissioning, and qualification in pharma production.

• Familiar with regulatory inspections (e.g., FDA/EMA) and audit readiness.

• Working knowledge of plant processes/equipment; mechanical concepts, electrical controls theory, and basic electronics.

• Project management skills spanning manufacturing, MES, and quality systems implementations.

• Proficiency with data acquisition and PLC programming tools (e.g., Rockwell suite), OSI PI/FactoryTalk Historian, MS SQL, and plant networking.

• Able to read/interpret electrical/mechanical drawings; review SOPs/WIs; excellent technical writing.

• Bilingual English/Spanish (written and verbal).

• Strong stakeholder skills; able to plan/prioritize multiple complex activities; self-starter who meets deadlines and exercises sound judgment.

• Willing to support irregular hours, rotating shifts, weekends, and holidays when necessary.

Preferred

• Experience with CMMS (Maximo).

• Deep knowledge of Rockwell Automation platforms; familiarity with Siemens and Wonderware/AVEVA.

• VMware vSphere and Microsoft SQL Server administration exposure.

• Experience with OSIsoft/AVEVA PI, FactoryTalk Batch, and MES Syncade.