Manufacturing Engineer IUS

Modis
Cincinnati, OH
15 May 2024

Vacancy expired!

Akkodis is seeking a Manufacturing Engineer for a Contract position with a client located in Cincinnati, OH. In this role you will be responsible for generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices

Pay/Salary Range: $28.00/hr. - $45.00/hr. | Monday-Friday 8AM-5PM.

Manufacturing Engineer job responsibilities include:
  • Provide statistical analysis of the date to support the reports.
  • Generation and implementation of change controls and engineering notices (ECO).
  • Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
  • Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
  • Evaluate, investigate, and document non-conformances incidents and/or protocol deviations.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
  • Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
  • Work on project teams with other internal departments, external vendors, and customers as required.
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
  • Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.

    • QUALIFICATIONS

    :
  • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
  • Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills. Ability to lead teams through complex projects and provide departmental technical leadership.
  • Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically.
  • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
  • Teamwork oriented and self-starter.

    • Must have experience
  • Medical device experience
  • Production floor experience.

    • Education and/or experience:
  • BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field. Lean/Six Sigma Green or Black Belt Certification is a plus. Experience in validations such as: manufacturing equipment, manufacturing processes, stability, or aging, required.
  • Minimum of 0-3 years of experience in the medical device and/or pharmaceutical manufacturing environment

    • If you are interested in this Manufacturing Engineer job in Cincinnati, OH then please click APPLY NOW. For other opportunities available at Akkodis go to . If you have questions about the position, please contact Misty Fugate at or

    Equal Opportunity Employer/Veterans/Disabled

    Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

    The Company will consider qualified applicants with arrest and conviction records.

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ;br>The Company will consider qualified applicants with arrest and conviction records
    • ID: #49938870
    • State: Ohio Cincinnati 45227 Cincinnati USA
    • City: Cincinnati
    • Salary: USD TBD TBD
    • Job type: Permanent
    • Showed: 2023-05-15
    • Deadline: 2023-07-13
    • Category: Et cetera