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Sr Automation Engineer - Utilities & Facilities

ROLE SUMMARY The Sr Automation Engineer - Utilities & Facilities will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable.  This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of clean utilities, black utilities, HVAC, and other systems within a sterile injectable manufacturing facility. ROLE RESPONSIBILITIES Support the operation and troubleshooting of manufacturing equipment and control systems Support reliability engineering for production and support equipment Provide on the floor operational support as needed Support all investigations and audits as needed Provide off-shift and on callsupport when necessary Responsible for Periodic review of the Automation Systems Responsible for assuring various user levels have appropriate, documented training and authorization for access to engineering managed computer systems Responsibility for managing regulatory aspects of the sites networked engineering data collection, monitoring and SCADA systems Responsible for implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for compliance Design and implementation support for minor functional and process changes, either smaller projects, remediation activities or capital projects Support future capital projects and assure site automation standards are followed Assist other departments in evaluating historical process/equipment data Provide automation guidance and training to other functional groups (ie. Operations, Validation, Maintenance, etc) Author and/or review design documents for projects and process changes Support FAT/commissioning/qualification activities as required Responsible for backup/archiving/restoring of Automation configuration and batch Develop and implement site automation standards for hardware and software Develop automation Standard Operating Procedures System Admin for all site SCADA systems, Data Historians, and Engineering Site-wide Software Applications System Administration for adding and disabling user access to Site Automation system Maintain Manufacturing level network, control level networks and Process I/O network. Demonstrate proficiency in cGMP, GAMP, software development life cycle, environmental, health and safety procedures to assure compliance with regulatory, policies and/or established guidelines.  Observe and notify any risk situation for the environment, health or safety.  Assure that all automation engineering initiatives comply with all regulatory agency requirements QUALIFICATIONS Education: Bachelor's degree in Engineering (Chemical, Computer, Mechanical or Electrical). Experience: 5 years of working experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment. Understanding of SOP's, Change Control and all related GMP Pharmaceutical systems. Excellent communication and interpersonal skills. Ideal candidate must have process automation experience with integrated manufacturing systems and ancillary equipment. Hands on experience with Siemens Apogee, Rockwell software platform, Allen-Bradley hardware, Wonderware, OSI Pi, HyperV, VM Ware and others. Familiarity with industrial communication networks. This job description indicates the general nature and level of work expected of the incumbent.  It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilitiesrequired of the incumbent.  Incumbents may be asked to perform other duties as required. English proficiency Computer Literate 4718348
Salary Range: NA
Minimum Qualification
5 - 7 years

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