3 days old

Quality Engineer

LI-COR Biosciences
Lincoln, NE 68508
  • Job Code
    1908168
Responsible for the oversight, review and approval of process-related activities and the generation and management of subsequent data. This includes the generation or approval of process validation and equipment qualification documentation. Requires thorough documentation practices, and good attention to detail and an understanding of GMP production activities. Requires strong interpersonal and technical skills to work effectively and efficiently with other departments and external customers to resolve problems and to achieve common goals. The Quality Engineer position requires expertise in process validation, equipment qualification and computerized system validation. This expertise acquirement will be determined by the Quality and Compliance Manager.

Professional Qualifications

Education

  • BS/BA with minimum of 5-year experience in a cGMP-regulated industry. Prior process validation experience is required. Prior auditing experience is beneficial.

Experience
  • Experience to include at least 3 year of industry experience post degree in a cGMP-regulated environment.
  • Experience with process development and process validation.
  • Experience with equipment qualification including computerized equipment.
  • Experience with process improvements and trend reporting.
  • Experience with Computer System Validation and 21 CFR Part 11 compliance
  • Experience with Windows operating environment and experience with Microsoft Word, Excel, and PowerPoint.

General
  • Follows written and verbal directions in various formats.
  • Manages people and projects easily and effectively.
  • Enjoys and works well with other people in a cross-disciplinary team environment.
  • Takes initiative and completes assigned tasks on time.
  • Able to effectively analyze situations and develop appropriate solutions.
  • Works quickly and accurately.
  • Comfortable with the use of computers and computer-controlled equipment.
  • Able to observe and record significant experimental results.
  • Performs job tasks safely, without endangering self or others.
  • Effective English reading/comprehension and writing skills.
  • Dependable, positive attitude and good attendance.
  • High ethics, integrity, honesty and patience.

Position Responsibilities

Specific

  • Design process validation and optimization protocols. Review and approve equipment qualification protocols. Identify and troubleshoot equipment or process defects. Review and approve final reports and analyze resultant data.
  • Assist in the execution of validation projects to ensure facility and utility systems, computer systems, process equipment and laboratory equipment are qualified in accordance with established regulations and approved site and corporate standards and procedures.
  • Work with other functional groups to develop protocols.
  • Assist in the adherence to site Validation Master Plans.
  • Participate in product or process improvement teams. Provide guidance to the teams to assure awareness of validation requirements and compliance.
  • Assist with obtaining documentation necessary for change controls, deviations and other GMP documents; and reviews documentation for accuracy and completeness.
  • Write, review and approve the creation / revision of SOPs, User Requirements Specifications (URS) and Master Batch Records (MBRs).
  • Participate in IQ/OQ/PQ/PV activities including the drafting or review of protocols and reports, PFMEAs and other risk analysis documents, qualifies, validates production processes
  • Determine quality improvement parameters by identifying relevant statistical methods
  • Assist with machine and process capability and performance studies
  • Assess compliance with applicable regulations within the manufacturing processes and recommends improvements to ensure that safe and effective products are produced
  • Train manufacturing personnel in understanding specifications, new product audits, procedures, environmental controls, and requests training or training support
  • Participate in internal/external Quality System audits

General
  • Light Work-Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly.
  • Other job related duties as assigned.






Posted: 2019-10-10 Expires: 2019-11-08
Sponsored by:
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Sponsored by:
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Quality Engineer

LI-COR Biosciences
Lincoln, NE 68508

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