Senior Engineer- Lab, Sterility Assurance

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

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 – Senior Engineer- Lab, Sterility Assurance

•  Location – Whitefield, Bangalore

This position will report to Sterility Assurance Lab Manager and is primarily responsible for laboratory contract support, external contract testing labs and internal primary lab contact for Quality Management System (QMS) documentation. This role will be responsible for the planning, designing, execution, documentation, data analysis and final report generation of microbiological studies done for Sterility Assurance for devices, drugs and Solutions, internally or at the contract testing facilities. The candidate should have a strong background in Microbiology Laboratory testing and should have a strong understanding of the scientific aspects related to Microbiology and Sterility Assurance.

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

Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance. Design, development &Technical Understanding of Microbial Method Validation & Sterilization Engineering principles for devices/ Solutions.         Solid Leadership skills, team orientation and understanding of organizational cultural attributes. Support and co-lead the set up and maintenance of contract testing labs and microbiological testing. Coordinate and track contract testing lab activities for drug products and medical devices, including new product development, test method development & validation, and investigations. Ensure R&D microbiology lab and documentation supports the company’s QMS and that the documents are audit ready and can effectively respond to auditor enquiries. Equipment procurement and assure necessary validations and documentation. Support Lab Manager to maintain lab operations.

Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)- Microbiology & Quality Assurance/Control. 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 Sterility Assurance and related controls for the products.
• Leading the Microbial study executions in the lab and compliant documentation to deliver on time, credible results.
  • Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries.
  • Assure appropriate investigations are conducted, as necessary, at contract labs. 
  • Support Lab Manager to maintain laboratory operations, including adequate documentation required from lab personnel and for lab equipment. 
• Where necessary, implement new procedures to support microbiological testing of products.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles.
• Provide regular/timely updates to Sterility Assurance Management.
• Assure all work complies with Baxter’s QMS and cGDP/cGMP/cGLP practices.
• Work with Global sites and Global testing Labs to drive the microbial testing’s technically and ensure execution excellence of the studies for quality and regulatory expectations.
• Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues.
• Determine process and structure of reporting test results between internal micro lab and contract testing labs.
• Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and reduction in cycle-time.
• Design and perform Sterility Assurance Assessments and Microbial validation studies in support of medical device, Solutions & pharmaceutical projects.
• Perform standard Sterility Assurance 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.
• 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 6 years or BS with minimum 8 years’ experience in sterilization validation or equivalent.
• Prefer experience with Microbiology method validation, Global sterilization regulations & TQM methods (e.g. "six sigma")
• Display a solid technical understanding of Microbiological principles and qualification practices & application of these principles on individual/small projects.
• Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies.
• Strong Microbiology background and experience.
• Demonstrated ability to utilize resources available to ensure compliant and required documentation for contract testing laboratories and the internal R&D microbiology department.
• Experience managing multiple simultaneous projects and work activities.
• In-depth knowledge of cGDP/cGMP/cGLP practices and compliant documentation.
• Effectively operates in, and capable of facilitating, cross-functional teams.
• Knowledge of medical devices and/or pharmaceutical industry.

Skills

• Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones.
• Proficient with Microbiological 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 globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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