The Lead Automation Engineer role will serve as the administrator of our facilities automation systems, and all production computerized systems to ensure reliable and compliant operation. The position will apply equipment and process understanding of pharmaceutical manufacturing including operational efficiencies, process design, specifications, vendor management, qualification, safety and asset lifecycle management. The Lead Automation Engineer will be responsible for being the lead on automation projects, providing guidance to the automation team. Major Position Activities &



Responsibilities:



Will be the Automation Team Lead providing guidance and assistance on automation projects.Will be the technical expert and administrator on computerized systems such as Allen Bradley, Honeywell and Wonderware.



Responsibilities:



will include user access management across all systems supporting facilities, manufacturing and packaging.Designs and performs routine maintenance tasks on computerized systems to ensure reliable operation and proper maintenance of backups.Has input on SOPs and practices related to computerized systems to ensure CFR Part 11 compliance with emphasis on data integrity.Provides daily support and oversight of site automation and leads periodic reviews of system performance to identify problem areas and drive continuous improvement.Provides end user training for the operator controls of these systems.Supports service work and system upgrades, including system administration tasks, coordination of vendor activities and qualification work.Provides ongoing support to maintenance staff to solve complex problems, understand and coach failure modes, and prepare technical solutions on computerized systems.Provides ongoing support to maintenance staff to solve complex problems, understand and coach failure modes, and prepare technical solutions on computerized systems.Will serve as project lead and/or technical subject matter expert on site automation and computerize system projects.



Who You Are:




Minimum Qualifications:



Bachelor's in Engineering (Computer or Electrical preferred), or equivalence of certifications and experience.10 or more years of experience in a manufacturing environment and 5 or more years in a pharmaceutical / drug manufacturing environmentRequires manual dexterity, physical agility and the ability to lift 60 lbs.Knowledge of CFR Part 11 (EudraLex Volume 4 Annex 11 and ISPE GAMP Guidelines)



Preferred Qualifications:



Building Automation Systems programming, troubleshooting and administrationKnowledge of Computerized Systems qualification and validationKnowledge of Supervisory Control and Data Acquisition systems (SCADA)Must have good written and verbal skills