Automation Validation Engineer

FCS is actively seeking a highly skilled Automation Validation Engineer for their top client in Hopewell Township, NJ. 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:

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.

JOB 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.

First Choice Staffing is proud to be an Equal Opportunity Employer and Drug Free workplace. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.