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Sr. Manufacturing Project Associate
Sr. Manufacturing Project Associate','18000AUE','!*!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 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.Summary:
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 Cephalasporins 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 and generate 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. Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.','!*!Education and/or Experience:
BS Degree in Science, Engineering or Math with 3 or more years experience. Masters Degree with 2 or more years experience.At least 1 year of direct experience with writing and executing validation protocols is preferred.
Understand scientific strategies and be able to invent new methods or new avenues of investigation.Good interpersonal/communication/influencing/negation skills.Good project management skillsAbility 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.A Career That MattersBaxter’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, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the LawEEO is the law - Poster SupplementPay Transparency Policy
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.','Quality','United States of America-Illinois-Round Lake','','Global Communications - Ops/R&D/Quality/Mfg Support','Full-time','Sr. Manufacturing Project Associate
Last verified - 1 day(s) 5 hour(s) ago [What does Last Verified mean?]
Round Lake, IL