SR Validation Spec
Hoover, AL
Req ID 50790BR
Business Title
SR Validation Spec
Business
Global Quality
Sub-Business
BioScience BioLife Support
Country
US
State/Province
Alabama
Location of Position
Hoover, AL
Shift_
1st
Job Description
SUMMARY :
The Senior Validation Specialist is responsible for planning, scheduling, execution and leading validation project assignments. Validation assignments including design, development, validation, qualification, and implementation of new and existing laboratory facilities, processes, equipment, and instrumentation systems, with a specialized focus on assay and test method validation. Leads multi-group validation teams in the development of validation philosophies and strategies.
ESSENTIAL DUTIES and RESPONSIBILITIES :
•Schedule, plan and manage installation, operation and performance qualifications of complex laboratory computerized systems that control equipment, utilities, facilities and laboratory instruments, with a special emphasis on assay /test method validation and analytical instrument comparisons. •Works in conjunction with Quality Manager, Director of Operations and Laboratory Operations Managers in the implementation, monitoring, and validation of laboratory equipment and systems. •Coordinates and interfaces with Operations, and Quality Assurance groups to assure successful project execution. •Ability to prioritize, manage and execute multiple projects utilizing Project Management methodology. •Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines •Ability to present a course of action to management and the project team using both written and verbal methods. •Contribute to investigations and coordinates technical analyses by using statistical tools and risk assessment analysis to implement solutions to problems and for improving existing validation processes or reassessments •Interpret and apply regulatory requirements including 21 CFR Part11. •Support regulatory submissions and regulatory agency inspections as required •Present validation packages during regulatory audits as a subject matter expert to demonstrate compliance of the validation and quality programs •Works with laboratory management to ensure timely closure of audit observations. •Champions continuous improvement within the validation department •Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence and BioScience Operating System (BOS) goals (including but not limited to 5S, Value Stream Mapping, Kaizen and Developing Defect Free Processes (DDFP) •Other duties and responsibilities as assigned.
Job Requirements
QUALIFICATIONS :
•To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. •The requirements listed below are representative of the knowledge, skill, and/or ability required. •Possess in-depth knowledge of GMP and regulations related to validation of laboratory equipment, instrumentation, computerized systems, and analytical assay / test methods. •Strong knowledge and understanding of applicable regulatory and quality requirements in an FDA-regulated environment and knowledge of 21 CFR Part 11. •Ability to manage and organize complex technical problems •Strong interpersonal communications skills with excellent technical writing abilities •Strong attention to detail and organizational skills with strong problem solving skills required. •Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint. •Result oriented with ability to adapt to changing priorities. EDUCATION / EXPERIENCE :
•Bachelor's or higher degree from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology) •Minimum of 8 years of validation experience in a highly regulated environment: blood services, pharmaceutical, biotechnology or related industry, including significant exposure to the regulatory requirements affecting validation. •Minimum of 3 years experience in the validation and qualification of laboratory equipment, instrumentation, computerized systems, analytical assay / test methods and analytical instrument comparisons. •Project Management experience. •Prior experience interacting with the FDA and other regulatory agencies is preferred.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
