Automation & Computerized Systems Engineer (Pharma)
Automation & Computerized Systems Engineer (Pharma)
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1 Vacancy
Job Description
Automation & Computerized Systems Engineer (Pharma)
Type: Contract
Schedule: MondayFriday
Overview
Were looking for an experienced Automation & Computerized Systems Engineer to support day-to-day operations and capital projects across Manufacturing and Utilities. Youll 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 Youll 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.
Employment Type
Full Time
