Automation Engineer II or Sr

Overview

The Automation Engineer is responsible for providing automation and engineering support for the installation, start-up, commissioning, testing, qualification, operation, and maintenance of process and automated equipment and systems within a newly constructed state-of-the-art GMP biopharmaceutical clinical and commercial manufacturing facility.

• Three to ten (3-10) years of relevant experience in pharmaceutical manufacturing or equivalently regulated industrial industry is required.
• BS or MS degree or equivalent in Chemical, Mechanical, Industrial or Electrical Engineering.
• Ability to successfully complete training on NFPA 70E is required.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

• Experience in network or server level knowledge.
• Experience with pharmaceutical manufacturing, design, and/or construction.
• Knowledge of; process, utility, and building control systems.
• ISA standards and practices for instrumentation.
• GMP guidelines, experience in generating controlled documents.
• PID control theories and techniques.
• computer aided manufacturing automation.
• Knowledge and ability in working with Allen-Bradley Programmable Logic Controllers (PLC). Certification is desired.
• Previous experience in a CMO and/or sterile pharmaceutical manufacturing preferred.

• Perform automation and instrumentation and control engineering design. This may include start-up of new facility systems and production equipment such as: building automation systems, water for injection systems, clean steam/critical utilities, and advanced aseptic manufacturing equipment (integrated fillers, isolators, lyophilizers, automated loading systems).
• Provide engineering support as part of the team for current and new product/equipment launches, and ensure issues being resolved and documented.
• Generate, execute and review design drawings and specification documents for new equipment.
• Support the operation and hands-on troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals.
• Adhere to site SOPs during daily activities and project deliverables while maintaining training qualifications.
• Automation lead for equipment/software FAT, field testing, and commissioning.
• Serve as the subject matter expert on automation systems for production and support equipment.
• Support execution of validation activities in support of new facility and equipment commissioning and continued qualification activities.

What Sets GRAM Apart from Other Employers

• BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost. Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
• Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
• PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
• WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
• PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
• PAY: Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!