Senior Engineer

1 day ago


Boston, Massachusetts, United States ACL Digital Full time
Job Title: Senior Engineer

We are seeking a highly skilled Senior Engineer to join our team at ACL Digital. As a Senior Engineer, you will play a key role in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization.

Responsibilities:
  • Develop and lifecycle manage Physical GMP Test Methods
  • Lifecycle manage integrated testing machines
  • Develop and validate test methods

The ideal candidate will employ basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Requirements:
  • 3+ years of experience in the field
  • Bachelor's degree in a relevant field
  • Experience working in a regulated industry, exposure to GMPs
  • Mathematical background fundamentals of statistics
  • Knowledge of test method development, CAD design, Solidworks, mechanical modeling
  • Programming skills in R and Python

The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions. This may include, but is not limited to, the following:

  • Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols
  • Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
  • Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment
  • Developing, enhancing, automating, and managing test data
  • Network with manufacturing and quality organizations internal to ACL Digital
  • Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
  • Monitoring technological developments in the field & evaluation of new technologies

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