Single Use Technology Process Engineer

Location
Lexington, MA
Posted
Jul 21, 2021
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

Job Title:

Single-Use Technology- Process Engineer

Current Locations:

Lexington, MA

Position Description

AM is looking for a Process Engineer to join our organization to support day-to-day operations, troubleshooting of single-use process equipment, and improvement initiatives. The engineer will be responsible for the design and introduction of new single-use equipment to support GMP manufacturing. Participation in tech transfer activities may be required to ensure existing equipment or new equipment meets process requirements. The engineer will also support cross-functional initiatives to improve manufacturing processes, equipment, and facilities. The engineer may be required to perform small capital project management in support of initiatives to ensure completion of projects while adhering to budget, scope, and schedule requirements. Multi-tasking, independent problem-solving skills, and the ability to lead cross-functional teams to define user requirements will be key to the success of this position. An additional key to success will be experience with single-use technologies/equipment as well as knowledge of multiple disciplines including facilities, automation, instrumentation, and validation.

Direct Involvement Opportunities:

  • Work cross-functionally to define and author user and functional requirements, purchase specifications, equipment/component flow diagrams, instrument specifications, and other engineering lifecycle documentation.
  • Lead cross-functional teams to test (FAT/SAT), startup, commission, qualify, and troubleshoot process equipment.
  • Perform investigations related to process equipment to determine root cause.
  • Identify appropriate CAPA to prevent reoccurrence of issues related to the performance or functioning of process equipment.
  • Partner with peers in Manufacturing, Facilities & Engineering, Validation, Logistics, QA, QC, and Technical Development to specify process equipment in accordance with Client procedures and Good Engineering Practice.
  • Serve as a Subject Matter Expert (SME) for process equipment in regulatory inspections.
  • Ensure appropriate site SOPs and documentation are in place to support Client adherence to Good Engineering Practice with respect to process equipment.
  • Engage with company management, internal departments, external organizations, and other sites to effectively implement and maintain standards and procedures for the lifecycle of process equipment.

Qualifications, Skills, And Experience:

  • Bachelors degree or equivalent in Engineering, Science, or related discipline
  • 5+ years of experience working in a GMP manufacturing facilities role.
  • Experience with cell/gene therapy products and single-use technology is preferred.
  • Thorough knowledge of cGMPs, EU/ICH, and global regulatory requirements related to equipment lifecycle.
  • Thorough knowledge of ASME-BPE and single-use technology industry guides.
  • Previous experience in supporting GMP clinical and/or commercial manufacturing is desired.
  • Strong organizational, interpersonal, and communication skills to plan and accomplish goals.
  • Team-oriented approach to project management and problem resolution.