Automation EngineerBioPhase Solutions • Orange County, CA, US

Automation Engineer

BioPhase Solutions • Orange County, CA, US

30+ days ago

Job type

Full-time

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+.

Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!

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Automation Engineer • Orange County, CA, US

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