Process Specialist II

Baxter

  • Bloomington, IN
  • Permanent
  • Full-time
  • 1 month ago
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Summary

The Process Specialist II provides technical/process support as a Subject Matter Expert for the manufacturing filling line operations with the goal of maximizing production efficiency. The position is visible on the manufacturing floor. It has high interaction with the production team to resolve issues during manufacturing. Drives improvements in overall process and equipment effectiveness (equipment availability, operator efficiency and product yield).

Essential Duties and Responsibilities
  • Develop a solid understanding of filling line manufacturing processes / equipment – evolve into SME for assigned area. Equipment focus may cover syringe, vial or cartridge line / value stream, including component washer, depyrogenation tunnel, filling and stoppering machine, capper and tray loader. Preparation and operation of Lyophilizers is in scope of this position as well
  • As SME status achieved, serve as advisor to BLT relative to assigned equipment and processes
  • Develop a solid understanding Lean/Six Sigma tools: SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc. Utilize these tools to drive improvements in overall equipment effectiveness
  • Participate in cross functional continuous improvement initiatives that directly impact operations performance
  • Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost effective corrective actions to prevent recurrence
  • Support team deliverables for equipment related processes
  • Review process trends to identify areas of improvements, including: equipment downtime (PM’s, spare parts, equipment/tooling design), operator efficiency (set-up, tear-down, overall batch run speed) and product yield issues
  • Responsible for standardization/training of set-up and basic troubleshooting procedures for Production Leadership and SME identified Operators
  • Key member of the filling line Total Productive Maintenance (TPM) team
  • Ability to create, manage and approve Master Change Control, Equivalency Forms and Work Orders
  • Coach/mentor and train Maintenance Technicians and Production Operators
  • Act independently with minimal supervision
  • Maintain Grade A/B aseptic gowning certification; successful operator qualification/media fill performance
Job Requirements (Experience and Education)
  • Bachelor’s Degree and experience in manufacturing pharmaceutical operations
  • Understanding of Good Manufacturing Practices
  • Computer proficiency in Word, Excel, and Outlook and the ability to use enterprise software, such as BPLM, Maximo, Trackwise, etc.
  • Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems
  • Six Sigma Green Belt or Black Belt certification preferred; expectation will be to obtain at minimum a Green Belt certification.
Physical / Safety Requirements
  • Must be able to lift up to 50 lbs
  • Duties may require overtime work, including nights and weekends
  • Extended periods of standing and/or walking
  • Extended periods in Grade A, B, C, D production environments
  • Use of hands and fingers to manipulate equipment is required
Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Baxter