Industry: Pharmaceutical / Biotech

Job Category: Manufacturing – Automation

This position is responsible for the design, development, programming and implementation of process control systems for pharmaceutical manufacturing processes and plant facilities for full compliance with FDA regulations.   Support the facility, utility, manufacturing and packaging related control systems.  Troubleshoot control and instrumentation systems and resolve discrepancies.  Work with equipment vendors on purchases.  Programming, installation and configuration of automated systems.  Develop and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports and write standard operating procedures.    Participation on cross-functional teams to coordinate control related activities with external consultants, contract validation services, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations activities.

·   Design, specification, programming, simulation and testing of control systems, utilities systems, and building automation within existing and new facilities for full compliance with FDA regulations.

·   Provide support for all plant Automation, Process, and Robotic Systems. Analyze and troubleshoot electrical circuitry using schematics and test equipment.

·   Supports facility, utility, manufacturing and filling/packaging related control systems along with capital projects.

·   Engineer and lead department assigned control system projects, vendor resources and schedules, and other necessary control system project tasks.

·   Supports facility, utility, manufacturing and filling/packaging related control systems along with capital projects.

·   Review documentation, methods, equipment, and procedures to improve efficiencies.

·   Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments.

·   Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for the design, development, installation, qualification, and validation of existing and future control systems and building management control systems.

·   Other duties include, but not limited to, troubleshooting control and instrumentation systems to resolve discrepancies, install automated systems, configure automated systems, develop test strategies, execute test strategies, prepare protocols, execute protocols, prepare technical reports and write standard operating procedures.

·   Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support for cGMP Manufacturing and Utility control systems.

·   Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.

·   Work cross functionally with Validation, Facilities, Calibration, Manufacturing, Process, and Engineering efforts and other cross functional departments requiring controls related assistance and SME (Subject Matter Expert) expertise.

·   Maintains and optimizes the Calibration Data Base (Blue Mountain) as well as the Computerized Maintenance Management System (CMMS)

·   Periodically review automation documents, preventive maintenance, and standard operating procedures to ensure compliance with GMP, environmental, and safety regulations.

·   Develop corrective actions for automation anomalies and oversee investigations to prevent recurrence.


·   Responsible for observing all Company, Health, Safety and Environmental guidelines.

·         BS or Technical degree in engineering controls or a related field with 5-7 years of experience or MS/MBA with 3-5 years of experience or the equivalent combination of training and experience.

·         In-depth knowledge of PLCs, SCADA, HMIs, Vision system, Robotics and Visual Basic.

·         Proven ability to program PLCs, HMIs.

·         Effective project management skills.

·         Working knowledge of ControlLogix, Panelviews, RSView SE, RSBatch, Assest Centre, FactoryTalk, EPAS-4 and Wonderware a plus.

·         Understanding and knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.

·         Experience operating, qualifying or developing batch processes, pure water systems, compressed air systems, HVAC systems, Filling Units, Lyophilizers, Freezers and Refrigerators a plus.

·         Understanding and knowledge of ISA S88 and S95.

·         Some knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations and industry trends.


SKILLS AND CERTIFICATIONS [note: bold skills and certification are required]
Security Clearance Required: No
Visa Candidate Considered: No
Job Type: Full Time
Job Location: Danbury
State: Connecticut

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