Automation Engineer (onsite role in MA)

Role Summary

The Automation Engineer will be responsible for developing automation technologies and Manufacturing control systems to improve site productivity and quality and safety performance. In this dynamic role the Automation Engineer will ensure the success of Drug product manufacturing through an understanding and strong background in engineering, configuration, programming, installation, commissioning, maintenance and troubleshooting of process controls, automation, electrical devices and field instrumentation technologies.

Responsibilities

• Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.
• Understanding of cGMP processing with change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
• Experience with the following product platforms.
• Rockwell PLC Platform
• Emerson DeltaV
• Day-to-day Operational Support:
• 24 x 7 Onsite/On Call: Rotational Support
• Trouble shooting Support to Mfg.
• Be a knowledgeable SME for Upstream and Downstream Unit operations by
• Trouble shooting activities in partnership with the Plant Engineering & Maintenance teams to enhance manufacturing uptime through the highest reliability of Automation systems.
• Being responsible for continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process engineering and OPex to drive operational efficiencies.
• Responsible for collaborating within the AbbVie network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing AbbVie Global network.
• This role involves the application of automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred
• Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible for developing & maintaining Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP) including Administrative SOPs and Job Aids.
• Provide AbbVie User requirements to OEMs/System Integrators during the development of process control applications applying Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA), and development of Batch Reports using Manufacturing Execution System (MES) platform like POMS.
• Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore).
• Ability to communicate in the simplest business language at various partner forums in the workplace

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or related field is required.
• Minimum 2-4 years’ experience, developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience, including experience with new technology development for new product introductions.
• Direct experience with system development and validation, including development of system specifications (DS, FS, URS) and risk-based validation strategies, and validation protocol development and execution.
• Demonstrated knowledge of 21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries.
• Demonstrated problem solving skills and innovative thinking to develop and implement untested solutions.

Education

• Nil