Grand River Aseptic Manufacturing

Automation Engineer II or Sr.

Grand River Aseptic Manufacturing  •  Grand Rapids, MI (Onsite)  •  4 months ago
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Job Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

of this Position:

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.

Non-Negotiable Requirements:

  • 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.

Preferred Requirements:

  • 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.

Responsibilities Include (but are not limited to):

  • 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.

Full job description available during formal interview process.

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!

Grand River Aseptic Manufacturing

About Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing (GRAM) is a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges. We are committed to advancing patient care by providing our clients with the experience, technology, and quality record necessary for effective clinical trials and successful commercialization.

GRAM adds value for our clients through strategic partnerships with innovators in drug delivery devices, offering tailored solutions designed for autoinjectors and on-body delivery systems. Our emphasis on collaboration allows us to speed up the delivery of innovative therapies, ensuring that our clients' products reach the market and benefit patients into the future.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
Grand Rapids, Michigan
Year Founded
2011
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