Principal Eng, Sterility Assurance

  Medical Writing

Job title: Principal Eng, Sterility Assurance

Company: Baxter

Job description: This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis.

sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy

automation, software, and services. The company’s global footprint and the critical nature of its products and services

play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide

are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare

innovations that enable patient care.

Job Summary

Job Title – Principal Engineer, Sterility Assurance

Location – Whitefield, Bangalore

With minimal guidance, schedules and leads through the planning and execution of a smaller project or defined piece of a larger project for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs, and Solutions. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. The candidate should have a strong background of sterilization validation and should have a strong understanding of the scientific aspects related to sterilization and Sterility Assurance.

The incumbent will be required to have the knowledge & will be required to provide support in following.

Devises new approaches to complex problems through adaptations and modifications of standard technical principles, ability to prioritize multiple tasks. Supervises/coordinates an engineer and/or technicians on assigned work. Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & topics related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices/ Solutions. Planning, execution, and documentation of sterilization cycle development for Moist heat sterilization. Ethylene Oxide sterilization, Radiation sterilization Good understanding of Life Cycle of sterilization development, Assessment of result & to verify if anything goes wrong in the process. Strong Leadership skills, team orientation and understanding of organizational cultural attributes.

Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Quality Assurance, Validation. Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable.

Essential Duties and Responsibilities

  • Demonstrated competency in one or more of sterilization technologies including moist heat, radiation or ethylene oxide and aseptic processing.
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Effectively operate in and may facilitate cross-functional teams with guidance.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.
  • Contribute to technical feasibility analysis of complex research and design concepts for the sterility assurance and related controls for the products.
  • Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time.
  • Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device, Solutions & pharmaceutical projects.
  • Perform standard sterilization engineering assignments for application, validity, and conformance to specifications.
  • Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives.
  • Study and recommend techniques to improve existing products/processes and process controls.
  • Provide sterilization support for R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals
  • Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP).
  • Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.
  • Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.
  • Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles.
  • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
  • Develop reports and presentations on technical plans and results.
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Knowledge around microbiological aspects of Biological indicators, Adventitious Agents, and related microbiological concepts.

Qualifications

  • Master’s degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 8 years or BS with minimum 10 years’ experience in sterilization validation or equivalent.
  • Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods (e.g., “six sigma”)
  • Display a solid technical understanding of Sterilization Engineering principles and qualification practices & application of these principles on individual/small projects.
  • The position requires technical skills for device sterilization using Gas (EO/VHP) / Radiation, assessing critical changes & impact assessments, writing study rationale documents.
  • Technical writing skills, remote support for projects, strong interpersonal skills and with a quick adaptive mindset for the new technologies.

Skills

  • Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones.
  • Proficient with Sterilization validation principles and related testing for Biological indicators etc.
  • Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators.
  • Highly adept at grasping and solving complex problems using root-cause analysis techniques.
  • Ability to objectively identify technical solutions and make sound decisions
  • Project management experience for Quality & value improvement projects
  • Self-driven, resourceful, and able to work on multiple projects and priorities.
  • Strong organization, attention to detail, and documentation skills.
  • Strong acquaintance with technology, QMS tools and collaboration tools over the web: e.g. Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc.

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific

innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and

technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing

creative collaborations that bring our mission to life for patients every day.

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, 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Expected salary:

Location: Bangalore, Karnataka

Job date: Tue, 18 Jan 2022 23:27:51 GMT

Apply for the job now!

LEAVE A COMMENT