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Quality Engineer -

Company: Kelly Services
Location: Dayton
Posted on: April 9, 2021

Job Description:

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting direct hire, permanent opportunity as a Quality Engineer for a top biotechnology company in Dayton OH.--Title: Quality Engineer --Duration: Permanent, DIRECT HIRE positionLocation: Dayton OH area--Essential Duties and Responsibilities:

  • This position is responsible for providing Quality Engineering support for process validation, process improvements, compliance projects and manufacturing support.
  • Identify and assess regulatory and quality risks in manufacturing activities and processes per regulatory requirements for client's products. Work closely with the Quality Engineering and Site Operations and Engineering teams to plan, organize and perform commissioning, qualification and validation for defined processes, facilities, equipment and process controls that meet applicable regulatory and company requirements.
  • Employee will be familiar with the qualification of biologics/pharmaceutical facilities, manufacturing equipment/systems, sterilization processes, cleaning processes, environmental monitoring, and process validation runs.
  • Responsibilities include Construction/Commissioning/Qualification of Site Equipment (Freezer, incubator, Vacuum Ovens)
  • Provide quality engineering support for equipment qualification and process validations as required.
  • Assist, in a team-based approach, the development and improvement of manufacturing processes to ensure such processes meet client's standards of process capability, reliability, and repeatability.
  • Coordinate supplier and material qualification with manufacturing engineering teams and Supplier Quality team.
  • Collaborate on the design and implementation of in-process control and incoming inspection test methods, acceptance criteria and sampling plans & rationale.
  • Ensure effective quality by design support for process improvement activities and technology transfer to production floor.
  • Act as a Quality representative supporting issue identification and resolution by applying root cause methodologies.
  • Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Provide department support during FDA, Notified body, and other external or internal audits.
  • Provide department support during any product recall or market withdrawal.
  • Create, maintain, and support Quality System processes and procedures related to quality engineering activities.
  • Comply with all company policies, procedures, and SOPs.
  • Perform all other duties assigned by quality management.--Qualifications: --
    • Responsibilities include Construction/Commissioning/Qualification of Site Equipment (Freezer, incubator, Vacuum Ovens)
    • Site Level Quality Systems experience
    • Experience developing SOPs, performing process improvement and validation, calibration of equipment and product non-conformance, and technology/process transfer between manufacturing sites.
    • Working Knowledge of 21CFR Part 210/211/600 and/or ICH guidelines for pharmaceuticals (client is transitioning from Tissue to Pharma/Biologics)
    • Med Device experience would be considered but must have knowledge in tissue base products/procedures.--Education / Experience:
      • BS in Biomedical Engineering or Pharma related degree
      • Minimum of 3 years' experience in Quality Engineering in a regulated manufacturing site.
      • Some of amount of pharma/biologics/medical device experience is required
      • Experience working in pharmaceutical or biologic cGMP areas such as 21 CFR Part 210/211, 21 CFR Part 600.
      • Knowledge of statistical analysis tools and familiarity with equipment qualification and process validation.
      • Experience with Advanced Therapy Medicinal Products (ATMP), Tissue, or biologics is a plus.
      • Experience with Medical Device (21 CFR 820/ISO 13485) manufacture or regulated tissue processing (21 CFR 1271) is a plus.
      • ASQ CQE certification is a plus.
      • Proficient in Electronic Quality Management Systems.
      • Must be able to handle multiple projects concurrently.
      • Strong Analytical Skills, Critical Thinking and Problem-Solving Skills, Attention to Detail.
      • Strong Communication and Team working skills, with ability to influence decisions.
      • Travel Requirements are up to 10% (will be supporting facilities in Dayton and Vandalia OH)--Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira () for immediate consideration.Why Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Dayton , Quality Engineer -, Engineering , Dayton, Ohio

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