Automation Engineer

Description

As an Automation Engineer, you’ll lead technical efforts with vendors and contractors, oversee system design and validation, and support automation for manufacturing and building systems (e.g., HVAC, water, cell culture, purification). You’ll help develop automation software, electronic batch records, and data systems, while ensuring compliance and efficiency. This role involves cross-functional collaboration, user training, SOP maintenance, and quality investigations. Ideal for those passionate about biotech and automation. Responsibilities -Provide technical direction to engineering firms, equipment vendors, support contractors and construction resources including vendor acceptance testing and startup validation -Partner in the design of automation software and strategies (process and supervisory control, electronic batch records, data collection, building management and other auxiliary systems) -Support building utilities and manufacturing equipment with a focus on building automation systems, HVAC, water systems, cell culture and purification processing -Interface with manufacturing and other end users of the system and implement necessary changes to improve the system's overall efficiency including training -Maintain standard operating procedures including recipe authoring and technical content development for digital systems while working with automation processes and systems -Partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions

Additional Skills & Qualifications

BS in Engineering required 3+ years of Manufacturing Industry Experience, biopharmaceutical or medical device manufacturing preferred Experience in supporting production process support within a GMP manufacturing setting Direct knowledge of FDA cGMP regulations/requirements for manufacturing clinical biopharmaceuticals Experience with GxP system implementation, procedures and documentation System Knowledge: Aveva PI or OSIsoft or Wonderware

Experience Level

Intermediate Level