Career Category

Information Systems

Job Description

Role Description:

• Lead complex operational plant troubleshooting efforts and investigation of production process, equipment, systems and code/configuration
• Perform Root Cause Analysis, develop corrective and preventive actions and implement the solutions to prevent recurrence
• Work closely with stakeholder to ensure production supply
• Collaborate with cross functional team to resolve incidents, events or deviations
• Provide operational support to the GMP processes including some off-hours on-call support
• Support plant improvement initiatives and projects
• Active involvement in proposing the direction and implementation of the automation control
• Make changes to manufacturing process control under strict GMP change control management process to optimize processes and maintain compliance
• Update or develop standard operating procedures, work instructions, functional / design specifications associated with automation control and system
• Support engineering process performance management, audit and inspection
• Responsible for the execution of all design, build and run service (and system) activities
• Provide training to plant personnel on automation control process
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
• Promote Safety, Quality and Compliance culture and continuous improvement mindset that lead to plant safety, quality and compliance to regulatory requirement
• Support Service Owner and System Owner roles for DeltaV and PLCs at ASM

Education / Licenses

• Bachelor’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience
• Associate’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and/or 4 years of directly related experience
• High school diploma in Engineering, Information Systems, Computer Science, or Life Sciences / GED and 8 years of directly related experience
• Knowledge of DeltaV DCS is essential

Relevant Experience

• 4+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries
• Hands on experience with automation systems and be knowledgeable in Emerson and Siemens technology

Competencies / Skills

• Demonstrated ability to lead and manage small projects and work effectively as a team player
• Experience supporting information interfaces, data conversion and network infrastructure
• Working knowledge of pharmaceutical/biotech processes
• Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
• Working knowledge of EHSS requirements
• Team player who can work with a diverse group of people
• Able to work independently
• Proactive and willing to take on challenges
• Experience with installation, administration, and troubleshooting computer data networks and servers is preferred
• Define, measure and improve system performance based on tangible metrics

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