Manager, Sterility Assurance and Cleaning Validation
BaxterBloomingtonUpdate time: January 24,2020
Job Description

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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 Manager, Validation is responsible for the oversight and management of validation associates who execute validations for new projects and maintain the current sterilization, formulation, filling operations, and support systems in a validated state in an aseptic manufacturing facility. The Manager is responsible for developing, managing, and implementing validation strategies to ensure products meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements, and interacts with Baxter Corporate Sterilization Council and implements applications in the Bloomington facility. This position reports to the Director, Technical Services.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

  • Sterility Assurance and Cleaning Validation
    • Oversight for the development, completion, and maintenance of documentation for protocols, Validation Master Plans, and Validation Summary Packages.
    • Interacts with potential customers to define product validation activities (technical capability/feasibility, component and equipment options, risk assessments, constraint analysis) and to understand customer regulatory requirements.
    • Maintains HEPA certification program for the filling complex.
    • Directing or participating in: performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce process variability.
    • Reviews and approves failure investigation reports to ensure a thorough investigation, root cause analysis and corrective/preventive action.
    • Acts as advisor to reports to meet schedules and/or resolve technical problems.
    • Oversees the site aseptic media simulation and intervention risk management program.

  • Management Responsibilities
    • Scheduling, planning and managing staff in multiple validation projects to provide documented evidence of validated equipment, control systems, and processes.
    • Identifies and manages Value Improvement Projects (VIPs) with the objective of achieving the highest quality, reliability and cost-effectiveness.
    • Demonstrates a strong commitment to developing and sustaining a strong cross-functional leadership team and creating a lean enterprise.
    • Creates a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
    • Participates in customer and regulatory audits.
    • Develops and administers budgets, schedules and performance reviews.

Qualifications

  • Bachelor’s degree required, preferably in a science or engineering related field. 
  • A minimum of 5 years related experience in aseptic processing validation within a pharmaceutical, biotech or related industry. 
  • Project management experience and/or previous supervisory experience is required.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.).
  • Proficient in 21 CFR 210 & 211 and EU Annex 1 compliance expectations.

Physical / Safety Requirements

  • Ability to meet Grade C gowning requirements.
  • Duties will require overtime work, including occasional nights and weekends.
  • Use of hands and fingers to manipulate office equipment is required.
  • Position requires sitting for long hours, but may involve walking or standing for periods of time. 

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.
                                                                                                                                                               
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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.

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