Automation Engineer II
About The Position
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Automation Engineer II is responsible for designing, implementing, and supporting, control systems. Support manufacturing group with any issues related to operation or use of control systems. Responsible for timely completion of work orders, deviations and change controls related to control systems. Responsible for generating test scripts related to control system changes. Support investigations to identify root causes and required changes to fix. Responsible for generating and maintaining control system documentation: functional specifications, I/O Lists, wiring diagrams etc. Collaborate and support external departments. Essential Duties and Responsibilities: Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and PCI DI guidelines. Provide process automation (SCADA, PLC's, HMI's) programing and building management support. Perform troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software. Maintain the Historical database, Factory Talk PI Historian, and local historical solutions. Support and maintain reporting services and report creation. Hands on support for operations, facilities with troubleshooting and issue resolution with respect to computer and automation systems. Develop and execute data backup procedures and disaster recovery strategies of automation systems, always ensuring data integrity and security. Write cGxP documentation such as SOPs, change controls, incidents, and deviations, planned deviations, and installation qualifications. Ensures documentation complies with cGxPs and other applicable regulations relating to GXP automated and control systems. Provide 24/7 on-call shift Support as required.
Requirements
- Bachelor’s degree in engineering, Computer Science, or related field
- Proven experience as an Automation Engineer, preferably in the pharmaceutical industry
- A minimum of 3-5 years’ experience programming and or troubleshooting PLC’s and HMI/SCADA applications, preferable in a qualified environment
- Experience with troubleshooting field instrumentation: pressure, temperature, proximity switches, scales and level transmitters
- Experience troubleshooting control panel electrical circuits <=120V
- Experience with Microsoft SQL Server Databases including running queries, troubleshooting stored procedures and configuration of security and backups
- Experience with FactoryTalk Historian database or OSI PI: configuration of points and ability to check data archives
- Knowledge of cGxPs, 21CFR part 11
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, and Visio
- Excellent organizational skills
- Excellent communication skills both oral and written
- Able to read/interpret engineering drawings and design documents
- Ability to read and interpret engineering drawings, P&IDs and electrical schematics
- Ability to assist customers in a pleasant, non-technical manner for problem resolution
Responsibilities
- Designing, implementing, and supporting control systems
- Supporting manufacturing group with issues related to operation or use of control systems
- Timely completion of work orders, deviations and change controls related to control systems
- Generating test scripts related to control system changes
- Supporting investigations to identify root causes and required changes to fix
- Generating and maintaining control system documentation: functional specifications, I/O Lists, wiring diagrams etc
- Collaborating and supporting external departments
- Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and PCI DI guidelines
- Provide process automation (SCADA, PLC's, HMI's) programing and building management support
- Perform troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
- Maintain the Historical database, Factory Talk PI Historian, and local historical solutions
- Support and maintain reporting services and report creation
- Hands on support for operations, facilities with troubleshooting and issue resolution with respect to computer and automation systems
- Develop and execute data backup procedures and disaster recovery strategies of automation systems, always ensuring data integrity and security
- Write cGxP documentation such as SOPs, change controls, incidents, and deviations, planned deviations, and installation qualifications
- Ensures documentation complies with cGxPs and other applicable regulations relating to GXP automated and control systems
- Provide 24/7 on-call shift Support as required
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
