The company is looking to improve site productivity, quality, and safety performance through automation technologies and Manufacturing control systems.
Requirements
- Minimum 10 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.
- Experience with automation technologies
- Experience with Manufacturing control systems
- Experience with PLC systems
- Experience with AI and machine learning
Responsibilities
- Identify opportunities for automation improvements to Manufacturing productivity, quality, and EHS (environmental, health, and safety), including technology options, vendor identification, and project business cases.
- Technical lead for automation equipment and control system design, including development of system and user requirements, laboratory testing, vendor management and qualification, and integration activities.
- Subject Matter Expert (SME) for automation technologies related to the development of new products and Manufacturing processes to ensure Design for Manufacturability (DFM)
- Lifecycle management of new or existing on-site control systems
- Provide technical support to all Manufacturing control system related issues, including troubleshooting and optimization.
- Assist the site Automation Assoc. Dir. with group management responsibilities including task prioritization, change management assignment and oversight, tracking lessons learned, etc.
- Technical lead for automation equipment and control system design, including development of system and user requirements, laboratory testing, vendor management and qualification, and integration activities.
Other
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Computer Science, or related field is required.
- Ability to provide technical program leadership, including external vendor management and lead cross-functional team including internal and external resources.
- Demonstrated problem solving skills and innovative thinking to develop and implement untested solutions.
- Ability to work with Key Stakeholders: S&T, Manufacturing, EH&S, Quality, Manufacturing Services, Facilities
- Ability to prioritize tasks and manage change
