Process Automation Engineer

PROCESS AUTOMATION ENGINEER SUMMIT, NJ 100 % Onsite Position . Project Description:

• The Automation Engineer is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply.
• The Automation Engineer is responsible for performing troubleshooting, maintenance, qualification, and validation activities for GxP process automated systems (PAS) while considering industry best practices.
• The Incumbent collaborates with SMEs from the Process Engineering, Manufacturing Operations, and Quality groups to ensure automation requirements are satisfied in support of the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
• Partner with the Process and Technology group to deliver integration needs with the Site Manufacturing Execution System and Data Historian .
• Participate with technical teams to drive execution of PAS testing .
• Drive and support the resolution of critical PAS production issues .
• Use policies and procedures required for troubleshooting, maintenance, qualification, and validation .
• Support development of life cycle documents and system requirements .
• Review and execute Quality System activities with oversight, i.e., Deviations, CAPAs, Risk Assessments, Investigations and Root Cause Analysis .
• Support PAS change initiatives and the implementation of process improvements .
• Support the tracking of team metrics and manage completion of objectives and projects .
• Automation Engineers generally work in an office environment, however trips to the manufacturing areas and remote sites are required.
• For this reason, Automation Engineers must have:
  • Ability to perform physical maintenance tasks with strength and mobility on process automation equipment, instrumentation, mechanical components, etc.
  • Ability to work in areas where posted Universal Precautions must be observed and practiced .
  • Ability to work daily with potentially harmful and/or hazardous agents including blood borne pathogens, asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.
• Position Handles Hazardous Materials .

Required Skills:

• Bachelor's Degree required (science or engineering is preferred) .
• 4 or more years of manufacturing support or related experience in the biopharmaceutical industry .
• Prior Biologics/Cell Therapy experience is highly valued but not required .
• Demonstrated expertise in PAS, specifically Emerson Syncade, Emerson DeltaV, and OSI PI .
• Experience and ability to troubleshoot Control Systems, PCs, etc.
• Understanding of engineering documentation such as P&IDs, Process Flow Diagrams and SOPs .
• Understanding of ISA S88, S95 and Batch Processing .
• Foster strong internal and external team relationships to achieve common goals .
• Promote a mindset of continuous improvement, problem solving, and prevention .
• Knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations .
• Experience with the start-up, validation, and licensure of new manufacturing facilities .
• Possess strong verbal/written communication skills and ability to influence at all levels.

This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: ALPHA'S REQUIREMENT #22-00946 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE