Engineer, Facility/Calibration

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.

General Responsibilities

• Perform calibrations, diagnostics, and maintenance of industrial process control instruments or systems, laboratory instruments and analyzers, and support utilities in a cGMP environment, while minimizing instrumentation and equipment downtime.
• Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.
• Perform instrument calibrations for process, utility and analytical equipment and systems
• Troubleshoot and repair site instrumentation and control system issues
• Perform advanced maintenance and repair activities on equipment and systems used in Manufacturing, Process Development, QC or other areas of the site.
• Work in a highly productive, accurate and efficient manner to maximize the activities completed.
• Ensure work is appropriately communicated to system operators and key stakeholders.
• Ensure work order documentation is completed accurately and completely.
• Identify waste, workflow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation.
• Perform troubleshooting, installations and repairs of complex instrumentation on production, laboratory and facility systems, ensuring all systems and devices are calibrated in accordance with manufacturer's specifications.
• Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.
• Complete calibration work orders and engineering change controls within the allotted time.
• Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP's.
• Assist in qualification activities related to Instrumentation and Process improvement projects.
• Assist in the development of investigations and initiation of any documentation resulting from conditions of instrumentation.
• Utilize skills and experience to achieve the safe and accurate completion of tasks and projects in support of plant operations.
• Assist in the creation or modification of technical documents and SOPs.
• Effectively interact and communicate appropriately with Manufacturing, Quality, Technology, Engineering, and other departments to ensure satisfactory performance of instruments and systems.
• Collect and organize technical data from equipment manufacturers, equipment users, and engineering personnel.
• Assist with identification, purchase, and organization of spare parts.
• Demonstrated proficiency to monitor, trend and analyze data to make corrections or recommendations.
• Provide support - this may be outside of normal working hours including nights, weekends and holidays.

Requirements:

• BS in Mechanical, Electrical, Bioengineering Engineering or other related technical area preferred, or a combination of relevant experience and education.
• 5 years' experience as field or facility support engineer with experience in instrumentation or calibration and equipment maintenance within the biotech/pharma industry.
  
  Experience w/ biologics manufacturing process instrumentation and control and/or analytical instrumentation desired.
• Ability to write, read and interpret SOPs, engineering documents and schematics.
• Thorough knowledge of the fundamental operating principles of industrial process instrumentation and systems.
• 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