QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA   Responsibilities: + Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment in second shift. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.  + Support non-standard shift organization including first, second, night, 12 hours and/or weekends shifts (24/7 operation) + Provide solutions to a variety of technical problems of moderate scope and complexity. + Function as a technical expert to equipment or systems regarding troubleshooting operations. + Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. + Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications. + Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). + Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. + Develop specification, engineering documents, SOP and operating standards. + Troubleshoot and resolve equipment, automation or process issues in the field. + Operate specialized laboratory equipment and computers as appropriate. Qualifications: + Bachelor's degree and background in Mechanical, Electrical, Process Control and/or Chemical Engineering  + 2 years of Engineering and/or Automation experience. + Background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. + Working knowledge of pharmaceutical/biotech processes. + Familiarity with validation processes and documentation in a highly regulated environment. + Comprehensive understanding of validation protocol execution requirements. + Validation Protocol Writing  + Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs. + Knowledgeable on Rockwell Automation Factory Talk & ControlLogix PLC Platform. + Knowledgeable on Rockwell SLC500 PLC families Controllers. • + Knowledgeable on Rockwell Automation FTView SE and FTBatch systems. • Knowledgeable on DeviceNet technologies. + Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services. + Work schedule flexibility to support 24/7 operations. + Knowledge of ASTM 2500, ISA S88 and S95 techniques - Batch processing a desired advantage. + Knowledge in Databased SQL programming language + Automation hands on experience (PLC/SCADA Systems). + PLC/SCADA Programming + Certain Knowledge in Computer Administration (Windows 10/11/ Microsoft Server 208 – 2022) + Availability for 12 hours day shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR