Automation/Controls Engineer

Location: Chicago Consulting
Department: Azzur Chicago, LLC

Job Description


The Automation Engineer works under the direction of the of Engineering management and utilize independent judgment to perform the day-to-day project duties of designing, developing, and releasing deliverables. This position requires a dynamic Automation engineer with broad technical background. The Automation Engineer is responsible for designing, implementation, support, and maintenance of control systems in support of site goals and objectives. The Automation Engineer is responsible
for maintaining a stable, qualified, and highly available computing infrastructure and implementation and Validated computer systems. This encompasses work processes that originate with the identification of a new or revised system, the design, installation, commissioning to support validated systems, Additionally, through daily tasks, Automation Engineering supports of current project operations and ensures compliance with regulatory, corporate and site requirements.

JOB DUTIES 

• Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and LSNE DI guidelines
• Provide process automation (SCADA, PLC's, HMI's) programing and building management support.
• Provide automation engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, protocol review, and testing to meet end user requirements.
• Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software.
• Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines.
• Provide automation solutions involving retrofits, optimization, and acquisition of process systems. Automation support of Autoclaves, Glasswashers, Fill line, Freeze Dryers, Batch reporting system, Air Handling Units, WFI Systems, Reverse Osmosis skids and other utilities etc.
• Responsible for detailed design specifications of automated systems
• Maintaining the Historical database, Factory Talk PI Historian, and local historical solutions
• Supporting and maintaining reporting services and report creation.
• Identify opportunities to improve existing processes, equipment, systems, and infrastructure.
• Hands on support operations, facilities with troubleshooting and issue resolution with respect to computer and automation systems.
• Develops and executes data backup procedures and disaster recovery strategies of automation systems, ensuring data integrity and security at all times.
• Writes 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.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are
not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.


PROFESSIONAL SKILLS 

• Strong organization, interpersonal, oral, and good written communication skills.
• Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes.
• Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point,
• Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.

EXPERIENCE 

• A minimum of 7 plus years’ experience programming and or troubleshooting PLC’s (Allen Bradley Rockwell), preferable in a qualified environment.
• Prior experience with PLC ladder logic, Allen-Bradley PLCs, iFIX, GE Unicorn, Siemens, Factory Historian, Finesse Emerson DeltaV, RSView32, RSView32, ControlLogix Building Management System.
• Innovative and capable of developing alternative solutions to issues at hand.
• Knowledge of cGxPs, 21CFR part 11, and other international regulatory requirements and guidelines.
• Experience with computer systems Automation practices ISPE (GAMP).
• Ability to read/interpret engineering drawings and design documents. Ability to read, interpret and troubleshoot engineering drawings, P&IDs and electrical schematics.
• Ability to interpret PFDs, P&IDs and detailed Automation design documents.
• Excellent technical writing, communication, and presentation skills must be team oriented and a team player.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.

EDUCATION 

• Bachelor’s degree desired, (Bachelor of Science degree in Computer Sciences, Automation Engineering, Electrical Engineering, Chemical Engineering or Mechanical Engineering)
 
QUALITIES 

• Ability to read/interpret engineering drawings and design documents. Ability to read, interpret and troubleshoot engineering drawings, P&IDs and electrical schematics.
• Strong understanding of team and group dynamics.
• Hands on and agility to working in a fast paced CMO environment.
• Strong Technical writing skills, communication, and analytical skills.
• Ability to assist customers in a pleasant, non-technical manner for problem resolution.
• Proven ability to recognize symptoms, analyze system data, and take corrective actions when problems arise.
• Knowledge of cGxPs, 21CFR part 11, and other international regulatory requirements and guidelines

Physical Requirements 

• Must be able to gown appropriately and lift and/or move up to 50 pounds
COMMUNICATIONS & CONTACTS
• Interacts with all departmental staff.
• Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, 


Apply Now