Automation Engineer 1st Shift

QuvaBloomsbury, NJ
17hOnsite

About The Position

Our Automation Engineer supports, develops, and maintains automated systems used in pharmaceutical manufacturing. This role ensures that production equipment, control systems, and digital infrastructure operate reliably, efficiently, and in compliance with cGMP and regulatory standards. The engineer collaborates with cross‑functional teams to troubleshoot issues, implement improvements, and support new system installations or upgrades. Operates within legal and regulatory compliance, ensuring systems are maintained and operational within site and regulatory requirements. Capable of following procedures, documenting work as/when performed and maintaining a clean/organized workplace supporting site compliance and quality standards. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is an onsite role in Bloomsbury, New Jersey; Monday - Friday 6 AM - 2:30 PM.

Requirements

  • Must possess the ability to work effectively with all levels of organization
  • Demonstrated ability to build and maintain strong business and collaborative relationships, internally and externally
  • Must possess excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, and draw valid conclusions
  • Ability to think analytically and systematically
  • Aseptic Operator Qualification and Process Simulation
  • Proficient in technical writing and current computer usage (Word, Excel, PowerPoint, etc.)
  • Good working knowledge of regulatory guidance as it pertains to APIs and injectable drug products
  • Bachelor’s degree in electrical engineering, Mechanical Engineering, or another related field, with 5+ years’ experience in a manufacturing environment
  • Experience working with PLCs, HMIs, Robotics (Fanuc, Staubli), and SCADA systems, preferably Rockwell or Siemens platforms
  • Equipment/Instrument Calibration principles
  • Proven ability to adapt and manage effectively in fast paced, changing environment
  • 18+ years of age
  • Able to successfully complete a drug and background check
  • Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

  • Experience in aseptic processing preferred
  • Experience with FDA, GMP, and ISO standards preferred

Responsibilities

  • Provides technical skills and expertise to support operations, ensuring automated manufacturing equipment operates efficiently, including network configuration and integration principles, and the ability to work effectively with IT
  • Supports constant operations by trouble shooting machines, monitoring PLC issues, performing root cause analysis on complex issues, and executing improvements
  • Investigates automation incidents and problems to prevent recurrence including the development and implementation of corrective actions
  • Design and implementation of equipment and facilities related controls including PLC coding (Allen-Bradley/Siemens), HMI and SCADA systems
  • Evaluates automated and information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade
  • Efficient use of different software tools and computer applications including but not limited to Microsoft Office, PLC programming software, electrical schematic design software, HMI programming software, SCADA systems and industrial networks (Allen-Bradley/Siemens)
  • Effectively and accurately handles most technical questions and objections for assigned products
  • Maintains appropriate documentation for equipment and processes including change control, drawings, manuals, and validation
  • Streamlines workflows and develop automated laboratory processes and instrumentation systems, including collecting and documenting requirements, developing concepts, design, testing/validation, implementation, and training
  • Recognizes priorities and takes action; makes productive use of time
  • Understands and adheres to policies and procedures
  • Software validation, data integrity, GAMP 5 and 21 CFR part 11 experience
  • Operating and troubleshooting of Fanuc Robotics

Benefits

  • Set, full-time, consistent work schedule
  • Comprehensive health and wellness benefits including medical, dental and vision
  • 401k retirement program with company match
  • 17 paid days off plus 8 paid holidays per year
  • Occasional weekend and overtime opportunities with advance notice
  • National, industry-leading high growth company with future career advancement opportunities
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