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MassBiologics | Medicine for Better Lives

Automation Engineer III

Full-time, 40 hours

Mattapan, Massachusetts

Provides expertise in Automation systems, for cGxP regulated research and manufacturing. 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

• Leads in the development, programming, monitoring, testing, reporting and maintenance of GMP and non GMP Automation systems. May assist with the creation of design changes when necessary. Compiles performance statistics and reports as needed.
• Provide electrical, electronics, communications and instrumentation support to maintain skids in a manner that is safe and efficient.
• Develops and executes data backup procedures and disaster recovery strategies of automation systems, ensuring data integrity and security at all times.
• Develops infrastructure improvement plans and directs the procurement of Automation related hardware and software in a cGxP environment.
• Exercises independent judgment within scope of authority. When necessary, escalates issues to supervisor to determine appropriate authority level to ensure prompt and appropriate resolution within the context of organizational priorities.
• Proposes automation related solutions based on SME documented user needs. Obtains ratification to prioritize and implement automation related solutions. Performs automation related improvements, upgrades and repairs as necessary. 
• Performs risk and vulnerability assessments, including automation system audits. Leads the development of plans to anticipate and prevent potential automation related failures and ensures the resolution of any automation related failures that arise.
• Collaborates with quality and regulatory groups to manage and prioritize testing, qualifications, and validations to ensure consistent functionality and cGxP compliance.
• Performs electronic and paper documentation activities pertaining 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.
• Assesses the need and makes recommendations for end user training.
• Maintains up to date knowledge of industry trends and best practices.
• Maintains effective communication and relationships internally and externally to MBL.
• Performs additional job related duties as required.

• Bachelor’s degree in Engineering from accredited school or related field with a minimum 5 years of relevant experience or equivalent combination of education and experience
• Requires advanced 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
• Ability to read, interpret and troubleshoot engineering drawings, P&IDs and electrical schematics
• Working knowledge of Allen Bradley Compact/Control Logix platforms and I/O
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action
• Understanding of basic operating principles of Biopharmaceutical instrumentation and process control systems
• Prior experience in a cGxP regulated environment. Strong working knowledge of cGxP, 21CFR part 11, and MA data security regulations