Job Description

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech
  
  Engineering.
• Extensive understanding and background in programming, design, installation and lifecycle
  
  management of manufacturing process controls, automation and field instrumentation
  
  technologies.
• Demonstrated hands-on experience in developing process control strategies for New
  
  Product Introduction and New Technology Deployment for Clinical and Commercial Drug
  
  Substance Plant Operations.
• Direct knowledge of Automation design, experience in process control engineering and
  
  troubleshooting with GMP biopharmaceutical production facility equipment/systems such
  
  as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration,
  
  and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety,
  
  system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.)
  
  related to Drug Substance Plant Operations.
• 5+ years’ combined experience with the following:
  
  ○ Emerson Delta-V DCS system
  
  ○ Rockwell Automation SCADA and PLC Platform.
  
  Electronic Batch Reporting Systems Design and implementation
  
  experience.
  
  ○ Process Control Network design including network segregation
  
  ○ Process Control Systems: Virtual Infrastructure design and
  
  implementation and ability to perform advanced troubleshooting activities
  
  with IS.
  
  ○ System Integration using OPC, Foundation Fieldbus, Profibus,
  
  and DeviceNet technologies.
  
  ○ Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost
  
  estimate development, business case development, detailed design, engineering and
  
  validation documentation and project execution.
• The ideal individual must be a self-directed team player ready to mentor and develop
  
  engineering staff and embrace a team-based culture that relies on collaboration for
  
  effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
  
  Ability to perform independently, self-motivated, organized, able to multi-task in project
  
  environments, and skilled in communication, facilitation, and collaboration.

• Develop and maintain process control automation solutions utilizing DeltaV Distributed
  
  Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine
  
  Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Lead and support functional area projects focused on improving process
  
  equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug
  
  substance manufacturing technologies into clinical/commercial facility.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on
  
  process control issues related to plant operations.
• Lead and support new product introductions (NPI) or new technology introductions by
  
  performing automation engineering assessments, implementing automation system
  
  configuration changes and supporting engineering and process qualification runs as
  
  applicable.
• Lead and Manage Day-to-day Operational Support including:
  
  ○ 24 x 7 Onsite/On Call: Day to Day Operational Support
  
  ○ Troubleshooting Support to Mfg. Operations
  
  ○ Automation System Administration
  
  ○Automation System Operating Systems (OS) and HotFix assessments
  
  and rollout
  
  ○ Daily manufacturing and engineering work center team meetings
  
  ○ Preventative and corrective maintenance
  
  ○ Automation System spare parts management
  
  ○ Purposeful Presence on the Floor (PPoF)
• Provide Continuous Improvement initiatives including
  
  ○ Safety, Productivity and Reliability Improvements
• Automation Business Process Improvements including departmental
  
  Standard Operating Procedures (SOP)
  
  ○ Maintain Data Integrity Assessments with the current company and
  
  Industry standards
  
  ○ Collaborate with Drug Substance Plant network to enhance the automation design
  
  for Drug Substance Plant Operations