Sr Eng,Sterility Assurance

Job Description

Sr Eng,Sterility AssuranceApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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 BaxterBaxter 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 pharmacyautomation, software and services. The company s global footprint and the critical nature of its products and servicesplay a key role in expanding access to healthcare in emerging and developed countries. Baxter s employees worldwideare building upon the company s rich heritage of medical breakthroughs to advance the next generation of healthcareinnovations that enable patient care.Job SummaryJob Title Senior Engineer, Sterility AssuranceLocation Whitefield, BangaloreThis position is primarily responsible for the planning, designing, execution, documentation, data analysis and final report generation for sterilization cycle development, process qualification and Sterility Assurance studies for devices, drugs and Solutions. The candidate should have a strong background in Microbiology and should have a strong understanding of the microbiology aspects related to sterilization and Sterility Assurance.The Sterility Assurance Engineer will be required to have the knowledge will be required to provide support in following;Good understanding of the microbiology principles around sterilization and method validations required for the microbiological techniques related to Sterility Assurance. Design, development &Technical Understanding of Validation & Sterilization Engineering principles for devices. Planning, execution, and documentation of sterilization cycle development for Ethylene Oxide sterilization, Radiation sterilization (Steam sterilization/ Sterilization with heat will be an additional skill) Good understanding of Life Cycle of sterilization development + Assess results+ Verify if anything goes wrong in the process. Solid 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

• Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs 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 Renal 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

Qualifications

• Master s degree in a scientific discipline (Microbiology/Technology/ Science) with minimum 6 years or BS with at least 8 years experience in device 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 MattersBaxter s employees are united in a mission to save and sustain lives. We are passionate about applying scientificinnovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies andtechnologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuingcreative collaborations that bring our mission to life for patients every day.Equal Employment OpportunityBaxter 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 otherlegally protected characteristic.Reasonable AccommodationsBaxter 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.041545Apply Now Save Job,

Keyskills :
data analysisrisk analysisproject teamsremote supportwriting skillsquality systemdata collectionmicrosoft officetechnical skillsteam orientationprocess modelingquality assurance