Senior Automation Validation Engineer

JSat Automation

$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical, etc.) or equivalent.
  • 5+ years of experience in the process industry.
  • Expertise in designing and programming automation control systems.
  • Familiarity with DeltaV control systems.
  • Knowledge of SCADA, MES, and computer system validation is advantageous.

Responsibilities

  • Lead the design and development of manufacturing control systems for process operations.
  • Identify and analyze continuous improvement opportunities with clients.
  • Manage or support projects as the primary controls resource.
  • Develop validation documents adhering to FDA cGMP and GAMP standards.
  • Design, program, test, and validate process control automation systems.
  • Prepare and execute validation protocols for 21 CFR Part 11 compliance.
  • Manage on-site project resources and ensure timely completion of projects.

Benefits

  • Work in a dynamic environment with diverse client interactions.
  • Opportunity to travel up to 40% to different client sites.
  • Engagement in cutting-edge automation technology and design.
  • Potential for leadership in project management and resource management.
Full Job Description
Job Description
JSat Automation is hiring a Senior Automation Validation Engineer for their Blue Bell Office. This position can be expected to 40% travel to client sites.

This Engineer will be responsible for the following:

  • Lead the designing and development of manufacturing control systems in support of process operations.
  • Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
  • Manage or support projects as the primary controls resource.
  • 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.
  • Manage the activities of on-site project resources; define detailed plan necessary to complete approved projects on schedule and within budget.
  • 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.
  • Manage 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.


Requirements

  • We require a minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical, etc.) or equivalent with over 5 years' experience in process industry.
  • Experience/Knowledge of selecting, designing and programming automation control systems. Startup and commissioning of DCS, Batch, PLC and SCADA systems using distributed I/O.
  • Experience in Control Systems DeltaV
  • Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.
  • Project Management experience and Process Knowledge isa plus

Job Type: Full-time

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