Career Category

Job Description

Role Description:

• Lead and manage the development of new product launch, new capabilities and optimization operational project initiatives to facilitate technical transfer of new program into manufacturing and provide the automation solution
• Provides technical support for new equipment/process start-ups and operation
• Responsible for the execution of all design, build and run activities
• Ensure robust testing of new configuration features based on structure risk assessments
• Coordinate validation activities in collaboration with Manufacturing, IT, and QA
• Partner with cross functional teams to ensure end-to-end process design and system integration to maximize operational efficiency
• Identify opportunities to improve existing control processes and equipment by leveraging and setting industry best practices
• 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, effective countermeasures 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
• Provide technical guidance to team of engineers
• 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

• Doctorate degree in Engineering, Information Systems, Computer Science, or Life Sciences OR
• Master’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience OR
• Bachelor’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and 4 years of directly related experience OR
• Diploma in Engineering, Information Systems, Computer Science, or Life Sciences and 8 years of directly related experience

Relevant Experience

• 6+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries
• Hands on experience with automation systems and be particularly proficient in Emerson and Siemens technology 
• Demonstrated ability to lead and manage projects and work effectively as a team player

Competencies / Skills

• 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 with excellent interpersonal and communication skills and ability to interact with a diverse group of people at multiple levels within the organization
• Able to work independently and drive results on multiple assignments in fast-paced environment
• Excellent problem-solving skills and customer focused
• Proactive and willing to take on challenges
• Experience in supporting information interfaces, data conversion and network infrastructure
• Experience with installation, administration and troubleshooting computer data networks and servers is preferred
• Define, measure and improve system performance based on tangible metrics