Automation Engineer II

Company: UMass Biologics
Location: Mattapan
Posted on: January 27, 2023

Job Description:

Automation Engineer II







Minimum Salary



US-MA-Mattapan





Job Location



2 weeks ago(1/9/2023 4:06 PM)















Requisition Number



2022-42203





# of Openings



1





Posted Date



Day





Shift



Exempt













































































Overview



















GENERAL SUMMARY OF POSITION: The cGxP Automation Engineer II supports all of the Automation systems in an FDA regulated research and manufacturing environment. Ensures all automation systems are maintained through proper cGMP change management procedures. Troubleshoots automation performance issues. Recommends upgrades, patches, and new applications and equipment. Provides technical support and guidance to users. Ensures that MBL's Automation solutions are consistent with organizational goals, industry best practices, and regulatory requirements, including but not limited to cGxP and 21 CFR part 11.



























Responsibilities



















MAJOR RESPONSIBILITIES:

• Develops, programs, monitors, tests, reports on and maintains GMP and non GMP Automation systems. Assists with the creation of design changes when necessary. Compiles performances statistics and reports as needed.
• Exercises independent judgment within scope of authority. When necessary, escalates issues to appropriate authority level to ensure prompt and appropriate resolution within the context of organizational priorities.
• Assists with data backup procedures and disaster recovery strategy of automation systems.
• Makes recommendations with respect to the procurement of Automation related hardware and software in a cGxP environment.
• Proposes IS solutions based on SME documented user needs. Obtains ratification to prioritize and implement IS solutions. Performs automation related improvements, upgrades and repairs as necessary.
• Provides timely and appropriate automation related support and training to end users.
• Performs risk and vulnerability assessments, including automation system audits. Develops plans to anticipate and prevent potential automation failures and resolves any automation related failures that arise.
• Executes testing, qualifications, and validations to ensure consistent functionality and cGxP compliance.
• Performs electronic and paper documentation relevant to areas of responsibility. Writes cGxP documentation such as SOPs, change controls, incidents and deviations, planned deviations, and installation qualifications. Ensures documentation complies with cGxP and other applicable regulations.
• Supports projects and operations at MBL's Mattapan and SouthCoast facilities.
• Maintains up to date knowledge of industry trends and best practices.
• Maintains effective communication and relationships internally and externally to MBL.
• Performs additional duties as required.
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  Qualifications
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  • Requires a bachelor's degree in Engineering or related field (mechanical engineering preferred) with a minimum 2 years of relevant experience or equivalent combination of education and experience
  • Requires knowledge of LAN, WLAN, WAN IP routing, network security, network management, process automation (SCADA, PLC's, HMI's) and building management and building security systems
  • Prior experience in a cGxP regulated environment. Strong working knowledge of cGxP, 21CFR part 11, and MA data security regulations
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action
  • Demonstrated ability to train others
  • Ability to conduct complex troubleshooting
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
  • Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
  • Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
  • Demonstrated initiative through past experience
  • Ability to work effectively both independently and as a member of a team
  • Occasional travel may be required
  • Ability to work flexible and, at times extended hours to meet the business needs of a 24 / 7 / 365 manufacturing operation
  • Ability to routinely lift up to 50 lbs using proper lifting technique (monitors, servers, switches)
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

Keywords: UMass Biologics, Boston , Automation Engineer II, Engineering , Mattapan, Massachusetts