Principal Engineer - Validation
Hayward , California
November 11, 2016
Job Description :
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
This position will consist of managing process validations and packaging design verifications for new products and for commercial products This role would be best fit for an Engineer that possesses process validation and/or packaging validation experience as well as project management skills.  Proactive planning and coordination of projects are essential to maintain and continuously improve the quality, cost, and delivery of the products.  Process expertise, technical knowledge in packaging process controls and troubleshooting skills are vital to be able to react to unusual situations in a timely and cost effective manner. Project integration of all departments in a fully commercial manufacturing facility with none to minimal impact to production plan is a special challenge of the position.
Essential Duties and Responsibilities
  • Provides and coordinates process validation and packaging services associated with the optimization of existing processes and the implementation of new projects in a safe, cost effective and quality conscious manner
  • Monitors yield reports and other business indicators and perform data analysis as to identify areas for improvement
  • Schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
  • Perform analytical, statistical and engineering studies to support development of new equipment acquisition, improvement of manufacturing processes and the optimization of the utilization of resources
  • Drive the installation and qualification activities of new equipment; make modifications and improvements to actual equipment and support validation exercises
  • Assure that the appropriate statistical tools are used in the process validations and design verifications
  • Work as liaison between the Product development teams and Manufacturing during the projects life cycle
  • Support the Primary and Secondary Packaging manufacturing Teams
  • Lead investigation reports of non-conforming production due to packaging equipment failures
  • Lead investigation reports of non-conforming production due to validation failures
  • Ability to prioritize multiple tasks
  • May supervise/coordinate assigned work for engineers and/or technicians

Qualifications :
  • Must possess strong knowledge of packaging process validations and design verifications
  • Strong project management and leadership skills
  • Global experience and cross functional teamwork a major plus
  • Must be able to provide solutions that reflect understanding business objectives and cost implications
  • Experience with: c onducting / Supporting Validation / Qualification Strategies, test specification development or utilizing experimental design / DOE's in the medical device industry, verification/validation of manufacturing packaging equipment and processes, packaging design of interventional products - Design control and Design verification, design validation and design history files experience, experimental design; fundamentals of probability and/or statistical process control and  p roduct specification development; test method development; and risk management
  • Must have a working knowledge or training and demonstrated proficiency (e.g. project management, total quality management, statistical methods, problem analysis and resolution, material science, design of experiments, software development)
  • Evaluate and assess packaging components improvements (BOM's Modifications, Specification Evaluation, and Design Drawings Approval)
  • Must have experience or advanced training and demonstrate proficiency (statistical methods, problem analysis and resolution, materials science, design of experiments.)
  • Experience in short and long range project management desired
  • Excellent verbal and written communication skills in English
  • Teamwork oriented and excellent interpersonal skills at various organizational levels
Education and Experience
  • B.S. in Engineering
  • Must have 5-8 years years   related experienced required in the areas of GMP regulations that pertain to the business unit.

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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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 email to or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.

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