Assoc III, ValidationReq # JR - 023969 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 07/10/2020
Are you looking for a career that matters?
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.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and revalidations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits. Must not be allergic to Cephalosporins or Penicillin.
Essential Duties and Responsibilities:
- Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
- Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
- Review, generate, and approve quality documents including validation protocols, SOPs, change controls, and non conformance event records as required.
- Serves as a project lead for projects of intermediate scope with cross-functional teams.
- Ability to train and provide guidance to junior level associates on validation activities and procedures.
- Ability to interface with regulatory inspectors during compliance audits.
- Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.
- BS Degree in Science, Engineering or Math with at least five (5) years of experience.
- Direct experience with writing and executing validation protocols is required.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Good interpersonal/communication/influencing/negotiation skills.
- Good project management skills
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
- Direct or indirect industry knowledge.
- Ability to work independently or in teams
- Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces without restrictions.
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
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.