JT947 - SR. SOFTWARE ENGINEER

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:

• Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
• Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
• Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
• Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
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Qualifications:

• B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
• Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
• 5+ or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
• Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
• Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
• Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
• Preferred Experience using the following systems:
• Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
• Testing and Inspection machines for devices
• Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
• Cleaning Systems (Autoclaves, Depyro oven , COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
• Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
• Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
• Fully onsite 8am-5pm M-F, OT possible

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.