Automation Engineer

Location
Sarasota, FL, United States
Posted
Jan 01, 2021
Ref
13857327
Required Education
Bachelors Degree
Position Type
Full time
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

The incumbent will be responsible for the operational readiness of the process automation applications within the process scale-up facilities.

General Responsibilities:
  • Maintain life cycle management of control system and documentation within applicable procedural documents and industry guidance.
  • Maintains, troubleshoots and modifies all automation products associated with manufacturing equipment, monitoring systems, building manangement systems and all other support systems for the GMP and non-GMP operations
  • Lead use of new automated technologies into the site.
  • Determine equipment or system specifications and most cost-effective technology to be implemented.
  • Provides capital improvement plans with cost analysis
  • Manage automation contractors as required to complete required work on within project timelines.
  • Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
  • Communicate and partner cross-functionally with Engineering, IT, Quality, & Manufacturing as well as outside contractors as needed.
  • Effectively partner with Validation, Process Development, Manufacturing, Operations, QC and QA to ensure a quality and compliant manufacturing environment.
  • Maintain permanent inspection readiness and actively support regulatory inspections.
  • Interface with regulatory authorities as required to support Manufacturing Operations audits.
  • Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs).
  • Troubleshoot, resolution and improvement of automation applications, including batch and continuous control as well as operating system and control system interfaces.
  • Provide automation expertise for assigned projects.
  • Handle all activities with strict adherence to department procedural documents, GMP and process programs.
  • Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Continuously monitor, anticipate and permanently resolve issues that may arise during production.
  • Responsible for creating and maintaining SOPs to meet GMP requirements, CFR's and internal company policies.
  • Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing.
  • Problem solve any technically related issues impacting production.
  • Perform investigations of non-conformances related to automation systems.
  • Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
  • Execute change controls to update and upgrade automation systems and equipment.
  • Provide support - this may be outside of normal working hours including nights, weekends and holidays.

Qualifications:
  • BS in Computer Science, Electrical Engineering, Bioengineering or related technical field preferred, with a minimum of 5 years experience in supporting automation activities and a minimum of 3 years supporting GMP biotech/pharma manufacturing operations or a combination of relevant experience and education.
  • Experience in AB Wonderware, Finesse and Unicorn platforms is required.
  • Experience in Siemens, Honeywell and JCI BMS systems is highly desired,
  • Experience in system level validation testing.
  • Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
  • Experience writing and executing change controls.
  • Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.
  • In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.
  • Demonstrated good interpersonal skills, customer focus, and professionalism.
  • Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.
  • Experience with Start-Up & Commissioning of cGMP facilities highly preferred.
  • Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.
  • Strong skills and experience in MS Office.
  • Demonstrated ability to works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management.
EOE/DFW