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Engineering Support Specialist

2 months ago

Thousand Oaks, California, United States EPITEC Full time

Location: Thousand Oaks, CA or Cambridge, MA (commutable distance preferred)

Position Overview:

We are looking for an Engineering Support Specialist to contribute to our operations in either Thousand Oaks, CA or Cambridge, MA. The selected candidate will be placed in one of these locations based on their proximity and qualifications. This position is integral to the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) division, emphasizing project initiation, design, and execution.

Key Responsibilities:

  • Assist senior personnel in the development and management of Physical GMP Test Methods and integrated testing apparatus throughout their lifecycle.
  • Create, validate, and document testing methodologies, including the generation of Lifecycle Documentation (FAT/SAT, IQ/OQ) and Gauge Repeatability and Reproducibility assessments.
  • Support project definition through engineering analyses and evaluations for the installation of automated testing systems.
  • Conduct field assessments of current systems and provide engineering design recommendations.
  • Collaborate with Engineers to refine, develop, and execute automated experimental protocols.
  • Develop, enhance, automate, and oversee test data management.
  • Engage with manufacturing and quality assurance teams within the organization.
  • Ensure compliance with scientific standards and accurate documentation in accordance with SOPs.
  • Monitor advancements in technology and assess new innovations.

Ideal Candidate Profile:

  • Education: Bachelor's degree in Engineering or a related discipline.
  • Experience: At least 3 years of experience in a regulated industry with familiarity with GMPs. Experience in the medical device sector is highly valued.
  • Technical Competencies:
  • Strong mathematical foundation with a focus on statistics.
  • Experience in test method development, CAD design, Solidworks, and mechanical modeling.
  • Practical technical experience in a laboratory setting.
  • Programming skills in R and Python are advantageous.
  • Additional Qualifications:
  • Understanding of equipment and method validation principles.
  • Experience with optical measurement devices, force testers, and BLE testing.
  • Familiarity with Manufacturing IQ, OQ, and PQ processes.
  • Personal Attributes:
  • A passion for data analysis and modeling.
  • Intellectual curiosity and a capacity to quickly grasp new concepts and technologies.
  • Excellent verbal and written communication abilities.
  • Capability to manage multiple priorities and experience with MS Project.

Preferred Qualifications:

  • Experience in test method development and lifecycle management.
  • Proficiency in statistical analysis and Gage R&R methodologies.
  • Familiarity with automated testing systems and equipment characterization protocols.