Senior Quality Engineer

Baxter International-posted 2 months ago
$88,000 - $121,000/Yr
Full-time • Mid Level
Marion, NC
Computer and Electronic Product Manufacturing
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This is where your creativity addresses challenges. Provide hands on validation support to several facilities/utility and equipment qualifications that are planned for the site. The ideal candidate will have experience in one or more of the following areas: qualification of Automated Visual Inspection Systems, Automation Systems Validation, Analytical Laboratory Systems Validation (including analytical equipment), Computer Systems Validation, Formulation Equipment Qualification, Filling and Packaging Equipment, Clean Room Qualifications, and Water for Injection systems.

  • Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter Visual Inspection of Parenterals.
  • Must perform process validation, process capability, and process control studies for assigned projects.
  • Must support Manufacturing, QC, Engineering, and Quality Management departments with the development and implementation of new process/technology.
  • Will participate in and participate in medium to large size projects, own work you're doing, produce detailed requirements and analysis documents for work you're leading.
  • Partner with other support groups and manufacturing teams to complete work.
  • Ability to function optimally as a member of a team.
  • Responsible for ensuring the quality of facility systems validations.
  • This position will be implementing software driven systems while working with engineering and IT.
  • Must ensure computer systems and applications follow regulatory quality standards through validations activities.
  • Must be able to understand and debug applicable software while following the software life cycle procedures.
  • Ability to communicate optimally in written and verbal form.
  • Must perform all other duties and responsibilities as determined by supervision/management.
  • BS degree in Engineering Subject area (ME, IE, CHE, BME, EE, CE) with a minimum of 3 years of validation experience.
  • Quality Assurance and/or Validation in the pharmaceutical/Biotech industry experience is required.
  • IQ / OQ / PQ & Data Integrity (ALCOA).
  • Ability to work days, nights, holidays, and/or weekends as needed by the project timeline to meet manufacturing deadlines and facility shutdown/maintenance periods.
  • Soft Skills: Critical thinker, interpersonal skills, self-starter, teammate, sense of urgency, engaged, solution oriented.
  • Ability to work with a diversified multi-functional team across different plant locations.
  • Self-motivated and works well without direct supervision.
  • Ability to quickly learn and understand applications.
  • Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project, and other business applications.
  • Wonderware, Allen-Bradley PLC, nice to have but not required.
  • Medical, Dental and Vision coverage.
  • 160 hours of Paid Time Off and Paid Holidays.
  • 401K match.
  • Employee Stock Purchase Program.
  • Paid Parental Leave.
  • Tuition Reimbursement.
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