Automation Validation Engineer at First Choice Staffing, LLC (DE) in Lafayette, Indiana, United States

Job description

• FCS is actively seeking a highly skilled Automation Validation Engineer for their top client in the Lafayette, IN area. This is a direct hire / permanent opportunity offering a competitive starting salary, flexible work schedule, medical & health insurance, PTO/Vacation, Paid Holidays, opportunity for professional growth, and other great incentives!
• POSITION OVERVIEW:

Responsibilities

• The Automation Validation Engineer will include but not limited to generation and execution of Automation and Performance Qualification protocols using a risk-based strategy for downstream process and ancillary equipment.

Requirements

• Bachelor's, and/or Master's Degree in Biology, Engineering, Chemistry, and/or related subject.
• Minimum of 3+ years of professional experience working in the Pharmaceutical, Biotech, Medical Device, and/or similar FDA/GMP regulated industries.
• Technical expertise in automation, control systems and instrumentation in the biotech industry using PLC and other DCS systems such as Delta V.
• Practical knowledge of distributed control systems, and associated programming languages, including DeltaV, Allen Bradley ControlLogix PLC and Rockwell FactoryTalk.
• Previous experience in automation service activities including understanding Piping/Process & Instrumentation Diagrams (P&ID), reading and troubleshooting hard-wired control systems using wiring diagrams, and programming/configuration of Programmable Logic Controllers (PLC), or Distributed Control Systems (DCS).
• Experience in risk management qualification strategy, GAMP and Part 11 is preferred.
• Develop and execute commission and qualification protocols (AIQ, IOQ and/or PQ), and summary reports.
• Generate and review GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)
• Ability to work independently with minimal direct supervision, and coordinate activities associated with commissioning, qualification, or validation.
• Strong understanding of the GMP regulatory environment, validation, and associated subjects.

Skills

Required

• Automation
• Control systems
• Instrumentation
• PLC
• DCS systems (e.g., DeltaV)
• DeltaV
• Allen Bradley ControlLogix PLC
• Rockwell FactoryTalk
• Wiring diagrams
• Programming/configuration of PLC or DCS
• GMP regulatory environment
• Validation

Preferred

• GAMP
• Part 11