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Added 12 days ago
JA
Technical Operations Manager
JSat Automation
Glendale, CA
- $120,000 to $160,000 USD / year
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- $80,000 to $120,000 USD / year
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San Diego, CA
- $75,000 to $125,000 USD / year
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- $75,000 to $125,000 USD / year
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JSat Automation

Validation Engineer

Glendale, CA, United States

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Job details

Posting language: English
Posted: May 5, 2022

Original job description

JSat Automation is hiring a full time Validation Engineer with Pharma Industry experience.

The Validation Engineer will be responsible for the following.

Develop, approve, and execute process validation studies and protocols for cell and gene therapy manufacturing.
Design and develop manufacturing control systems in support of process operations.
Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices.
Design, program, test and validate process control automation systems.
Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements
Manage, document, and implement these upgrades through changes control procedures.
Execute capital projects including but not limited to:
Control system software development
Control system hardware design
Network design
MES system implementation
Recipe management
User requirement specification development
Process equipment installations.
SOP development and training on Automation Systems.
Troubleshoot, analyze, and resolve field control system issues.
Develop, review, and / or execute automation qualification and validation protocols.
Design, develop, and implement technical solutions by establishing integration strategies, configuring and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels and field devices.

Requirements

Chemical engineers preferred, with a minimum of three (3) years relevant experience.
Experience in Control Systems (Emerson DeltaV, Allen Bradley, Foxboro, Siemens, Honeywell). Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.

Benefits

Health, PTO, Retirement Plan

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More about this job

Skills

Pharmaceutical industry
Control systems
Process improvement
Control engineering
SAP IQ
Regulatory compliance
Software development
Design hardware
MES
Troubleshoot
Allen-Bradley
SCADA
Database management systems

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