Princ Engineer-Critical Systems
Req #: 1800013N_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/9/2018 3:12:50 PM
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.
Data Integrity will assume a new role at the site to project manage data integrity assessment and remediation efforts in the short term, and then construct, exercise, and continuously improve sustainable best practices for a data integrity program. This role will require tactical skills in support of technical system risk management and remediation (computerized lab, production, and enterprise systems) and project management, as well as strategic capability in the form of program development and ownership (including policies, procedures, leading governance and quality performance monitoring efforts, etc.).
Essential Duties & Responsibilities
- Oversight of the Data Integrity Quality System, including development and leadership of appropriate governance, development and institution of requisite policies and procedures, establishment of sustainable and effective means of quality performance monitoring, and training of colleagues on the principles of data integrity.
- Project Management accountability for the coordination of efforts amongst colleagues and contractors as they perform system data integrity gap assessments (legacy and new systems), identify gaps (current and anticipated) and associated remediation activities to sustain data integrity requirements for compliant computerized and paper based systems. Project management accountability will include scheduling, monitoring and reporting progress to management, and facilitation of option analyses and selection of gap assessment remediation options.
- Integration of data integrity requirements, philosophy, and best-practices into the computerized system validation lifecycles for quality control instruments, manufacturing production and data analysis systems, and local instances of systems.
- Lead cross-disciplinary efforts and teams to build, establish, and continually strengthen the quality systems linkages between the Data Integrity Program and other quality Systems.
- Serve as the primary Point of Contact (POC) with respect to data integrity initiatives and teams, including during audits and regulatory inspections.
- SME for Data Integrity
- Maintain contemporary knowledge of regulatory requirements, and industry trends, and enforcement actions to ensure and maintains a best-in-class Data Integrity Program.
- Develop validation plans and risk management plans including traceability analysis. Participate in higher level validation activities, specifically around development of test scripts and other documentation generated during system support and validation.
- Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
- Should perform unannounced data integrity surveillance audits
- Should participate in the investigation and corrective action for reported improper practice
- Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
- Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
- Review SOPs, audit reports, audit schedules/plans, and other documentation as required.
- Independently drive change management processes for routine changes
- Support other functions, other duties within the quality department as required.
Qualifications for this role
- Must have strong inter-personal skills, ability to manage projects, must learn quickly, must be intuitive, self-reliant, and possess excellent analytical skills and leadership ability.
- Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
- Knowledge of MS Office Suite is required.
- Fluent in English both speaking & writing.
- Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred.
Education & Experience
- Bachelor's degree in science, engineering, computer science, or related technical discipline.
- Minimum three (3) years of experience in a pharmaceutical production or laboratory environment.
- Experience in current Good Manufacturing or Laboratory Practices, CFR 21 Part 11 regulations, Good Documentation Practices, and other applicable regulations for validated computerized systems preferred.
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.