JT947 - SR. SOFTWARE ENGINEER

Company: Quality Consulting Group, LLC
Location: Thousand Oaks
Posted on: May 31, 2025

Job Description:

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated, and enthusiastic individual to join our team. In this role, you'll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:

• Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition systems (SCADA).
  
• Support projects focused on improving process equipment, utilities, and facilities, including sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical and commercial facilities.
  
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
  
• Develop detailed specifications, engineering documents, SOPs, and computerized system administration job plans. Test automation-based process equipment.
  
• Own and administer process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOPs and processes.
  
• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation, and control systems.
  
• Support new product and technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering runs.
  
• Devise innovative approaches to complex problems through adaptations and modifications of standard automation principles.
  
• Support a safe working environment by complying with environmental health and safety practices, rules, and regulations.
  
  Qualifications:
  
  
• B.S. or M.S. in Electrical, Chemical, Mechanical, or Biotech Engineering.
  
• Strong background in control system automation, specifically in design, installation, programming, and validation of automated processes.
  
• 5+ years of experience with Rockwell Automation FactoryTalk & ControlLogix PLC Platform.
  
• Ability to create, update, and interpret electrical design packages, including SDS, URS, IQ, OQ, VSR, and other validation documentation.
  
• Knowledge of S88 and S95 techniques; batch processing experience is a plus.
  
• Strong leadership, technical writing, and communication skills.
  
• Flexibility to support 24/7 operations, including on-site work and occasional after-hours support.
  
• Experience in developing automation strategies for new product and technology deployment.
  
• Preferred experience with systems such as Lyophilizer, Filling systems, Building Management System, testing and inspection machines, and clean utilities.
  
• Working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP, and DeviceNet technologies.
  
• Experience with cGMP procedures, change control, nonconformance, CAPA, and validation practices.
  
• Full onsite availability from 8 am to 5 pm, Monday to Friday, with potential for overtime.
  
  Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Keywords: Quality Consulting Group, LLC, Monterey Park , JT947 - SR. SOFTWARE ENGINEER, IT / Software / Systems , Thousand Oaks, California