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Title:  Senior Engineer, 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 write and execute validation protocols and reports.  The job contributes to the organization by providing validation of manufacturing and test equipment and processes for compliance to regulatory requirements. This individual will work closely with other engineers, designers, manufacturing, marketing, and regulatory staff to assure specifications are met with technically strong, high quality, cost effective designs following a defined development process. 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.
  • A minimum of 6 years of FDA validation experience for equipment qualification and process validation in a regulated industry such as Medical Device or Pharmaceutical; OR master’s degree in related field plus 4 years’ experience. Similar industries and job roles will be considered.

Preferred:

  • Experience in a high-volume manufacturing environment, i.e., production 1M+ annual, cycle time < 1 second
  • 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 with custom equipment procurement and qualification.

Skills & Competencies:

  • Strong understanding and application 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).
  • Proficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
  • Strong understanding and application of Good Automated Manufacturing Practice (GAMP)
  • Strong analytical and creative problem-solving skills.
  • Excellent verbal communication and technical writing skills.
  • Strong demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
  • Demonstrated technical coaching and leadership of peers.
  • Strong demonstrated ability to execute manufacturing validation deliverables.

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.
  • Prepare overall project proposals including cost estimates and schedule for designated projects.  Assign priority and schedule tasks to provide timely solutions to achieve results.
  • Delegate tasks to technicians and co-ops within the department.
  • Participate in cross functional teams.
  • Work with functional managers and partners to ensure project goals are met.
  • Provide technical guidance and coaching of other engineers.
  • Contributes to project planning and execution to meet schedule and budget requirements

 

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