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Title:  Engineer I, Manufacturing Validation

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE: Manager, Manufacturing Validation Engineering

 

PURPOSE OF POSITION: The primary purpose of the job is to provide Manufacturing Engineering support to the Manufacturing department, while providing support to Product Development, and R&D departments. The job contributes to the organization by providing validation of manufacturing and test equipment for compliance to regulatory requirements. Equipment complexity ranges from manual fixtures and jigs to fully automated assembly and test machines.

 

QUALIFICATIONS

 

 

Required:

  • Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university
  • Co-op experience in a Regulated industry such as Medical Device or Pharmaceutical

Preferred:

  • Experience with medical device manufacturing technologies (heat staking, ultrasonic welding, press assembly, and robotics, preferred).
  • Experience with medical device test methods (leak, pressure decay and mass flow testing preferred).
  • Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual, cycle time < 1 second.

Skills & Competencies:

  • Understanding of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation. 
  • Experience with the validation life cycle (planning, protocol writing, execution, report writing).
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
  • Experience with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
  • Understanding and application of Good Automated Manufacturing Practice (GAMP)
  • Demonstrated ability to support manufacturing validation deliverables.
  • Understanding in Mechanical design fundamentals.
  • Basic knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred).
  • Strong analytical and creative problem-solving skills.
  • Excellent verbal communication and technical writing skills.
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 

RESPONSIBILITIES:

  • Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
  • Create test protocols to challenge equipment performance against intended specifications
  • Execute protocols and write validation reports
  • Process Validation to meet regulatory requirements.  Includes writing protocols, execution of the protocol, and writing the validation report
  • Standard Operating Procedures creation, revision and implementation including necessary change order, training and verification activities
  • Develop test methods and fixtures to prove functionality of sub-assemblies and final product
  • Select appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes
  • Write and execute test method validations such as Gauge R&R studies
  • Provide project status to leadership

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati