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 manages the daily operation of a laboratory or group of laboratories under a single function, in conjunction with and under the direction of a Laboratory or engineering functional Manager as applicable. This individual is responsible for the efficient laboratory operation within their assigned area and for establishing and maintaining compliance with current Baxter Quality Management Systems.
- Performs and directs engineering support activities including, but not limited to; testing, components analysis and measurements, defects tracking, method development and validation, metrics gathering and reporting, and process improvement.
- Management and oversight of laboratory related activities & compliance for their groups lab
- Responsible for consistent communication between Lab or direct Manager and Technicians
- Responsible for all compliance and program driven activities and timeline commitments within their respective laboratories.
- Consider the aspects of Environment Health and Safety procedures to ensure that all activities within labs will support EHS targets and will not jeopardize the health and safety of employees and environment.
Essential Duties and Responsibilities:
Work with Functional Manager to maintain and manage the laboratory budget, including but not limited to annual and quarterly forecasts, monitoring and reporting.
Works on assignments requiring considerable judgement and initiative to resolve problems and recommended solutions and delegation of testing resource.
Preparation and authorship of Study (as appropriate) and laboratory related documents in accordance with Baxter's Quality Management System, (E.g. protocols, reports, standard operating procedures, Laboratory Manuals and the Master Validation Plan).
Ensures all planned studies in support of all phases of the product development lifecycle are completed on time and in compliance with relevant laboratory standards and regulations.
Maintain laboratory readiness and compliance in preparation for any and all FDA, TUV, Corporate and Divisional, Environmental, Health and Safety (EHS) audits.
Working with R&D Engineering staff and programs in preparation and authorship of Study related documents (protocols and test reports), sample preparation, product / sample shipments and equipment and product / sample storage logistics.
Personally or through assignment to laboratory staff, maintain laboratory equipment.
Develops, gathers and reports lab performance and quality metrics.
Advise Functional Management of continuous improvement opportunities and non-conformances.
Under the direction of Functional Management, maintains regular communication with study directors and engineering teams, including others as needed (other external functions/groups) in order to meet or exceed project Milestones.
Ensure the laboratory is properly supplied and available to meet project/testing needs, both in the short and long term
Establish and drive a lean / visual management approach to laboratory facility and equipment organization.
Participate in lab and cross-functional project meetings and initiatives as required.
Oversee/maintain laboratory maintenance duties and equipment (directly or via delegation to lab staff). See partial/example list below.
Assure all internal audits and safety reviews are performed regularly
Generates and reviews quality records generated in the laboratory
Ability to lead and influence others to achieve results
Proficient at coaching and mentoring multiple areas of specialization
Ability to use advanced technical knowledge to help members of the laboratory staff to troubleshoot problems
Proficient PC skills and the ability to apply these tools to data analysis with high proficiency with Microsoft Excel, MiniTab, SharePoint, ...
Ability to solve problems under conditions of uncertainty and ambiguity
Knowledge of Design Control regulmations, applicable lab safety standards, laboratory regulations, change control requirements and lifecycle management
Knowledge of quality philosophies, principals, methods, tools and standards of testing using statistical rationale
Demonstrates advanced skills across multiple areas of specialization
Bachelor's degree in the Engineering plus a minimum of 3 years experience in the Pharmaceutical or Medical Device fields. 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 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.
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.