Sup II-OpEx (Reliability)
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.
- Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects.
- Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring.
- Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
- Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
Perform/lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
Resolves technical, material and cGMP problems that may impact project deadlines. Provide guidance and troubleshooting assistance as needed during a deviation in the process.
Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
Provide a positive and equitable working environment emphasizing the Baxter Shared Values: Respect /Responsiveness / Results.
Sustain a clean and safe work area using 6S principles
Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Qualifications for this role
- Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
- Ability to manage multiple priorities in a manufacturing plant setting.
- Ability to analyze and interpret scientific and statistical data.
- Strong professional writing skills and ability to prepare technical reports.
- Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Strong assessment and troubleshooting skills.
- Ability to respond to detailed inquiries, and present information to groups and senior management.
- Ability to solve routine design, engineering problems with assistance
- May be required to supervise multiple groups/shifts.
- Overtime may be required at times.
- Good computer skills.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
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, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.