Automation Engineer

Job Description

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for an  Automation Engineer to work for a leading Greater Orange County area biotechnology company.

Salary: $106-159k/year depending on experience

Responsibilities:

• Design, implement, and maintain automation systems to keep the plant aligned with state-of-the-art automation technologies.
• Ensure timely and cost-effective project execution while meeting quality standards, approved Functional Specifications, and applicable regulations.
• Manage and execute automation projects, including coordination, progress tracking, quality, cost, and schedule control, providing regular updates to leadership.
• Develop Functional Specifications based on User Requirements and risk analyses.
• Support supplier selection by preparing comparative analysis of offers and recommendations, preparing purchase orders, and ensuring correct material reception.
• Supervise external suppliers during project execution within the facility.
• Prepare and oversee the execution of Change Controls for assigned systems and areas, ensuring proper documentation, testing, and drawings.
• Develop and execute Qualification Protocols or supervise external execution when subcontracted.
• Manage and maintain all assigned automation equipment, ensuring proper operation, troubleshooting, and repair. Maintain preventive maintenance plans to minimize downtime.
• Provide technical support to users to reduce system downtime and optimize production. Develop and maintain necessary system procedures.
• Document incidents, perform investigations, and implement corrective actions for assigned systems and equipment.
• Manage backup and restoration plans for the plant’s automated systems assigned.
• Enhance internal knowledge of automation applications to support maintenance and troubleshooting.
• Contribute to the training of plant personnel on automation-related topics.

Experience/Requirements:

• 5+ years in industrial automation within pharma/biotech or other regulated manufacturing
  • Must have GMP experience
• Hands-on development + troubleshooting on PLC platforms (e.g., AB, Rockwell other will be valued).
• SCADA/HMI Engineering - Practical configuration/support experience (AVEVA/Wonderware, WinCC other will be valued), incl. alarms and graphics standards.
• Experience with AVEVA Historian and OT data acquisition (OPC UA/DA, interfaces/collectors. Other historian platforms will be valued).
• Experience in SQL (joins, aggregates, views), DB connectivity troubleshooting; MS SQL Server preferred.
• Working knowledge of Annex 11 / 21 CFR Part 11 concepts, audit trails, security/access, ALCOA+.

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