Associate Scientist I-Validation

Bristol-Myers Squibb Syracuse, NY

About the Job

Description:

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
                                                                
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
 
The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY.

 

Summary\:
The Site Validation Services Group is responsible for Installation, Operational and Performance Qualification (IQ/OQ/PQ) of process equipment, in-process analytical equipment, validation of SIP processes and validation of critical process utility systems.  Responsibilities include validation work arising from change controls, capital projects, continuous improvement, shutdown/changeover activity, and ongoing revalidation programs.  The primary responsibility of this Validation Associate Scientist/Engineer I position is to support the qualification needs for equipment/facilities/utilities validation, including Sterilization-In-Place (SIP), initial qualification and support maintenance of qualified state as part of BMS Validation life cycle.  

Duties/Responsibilities\:
1.    Author, review, and execute protocols for general validation activities as required and final reports.
2.    Author, review, and execute characterization/development studies protocols and final reports.  
3.    Identify opportunities for process improvements, make formal recommendations and drive improvements to completion.
4.    Identify and assist with implementation of new technologies/procedures for Validation.
5.    Review standard operating procedures (SOP), and other cGMP documentation as required.
6.    Provide support and/or maintain requalification schedule adherence and ensure work is executed "right first time" in order to reduce equipment down time.  
7.    Maintain familiarity with BMS directives and industry guidelines on validation.

 

Qualification:

Qualifications\:

Direct experience or close familiarity with critical utilities validation (e.g. Pure Steam, WFI, Compressed Gases), and temperature mapping concepts is required (e.g. SIP, Autoclave, Freezer, Incubator, Warehouse, Cold Rooms). Experience supporting and maintaining Validation Requalification Program.  Direct experience or close familiarity with in-process analytical instrument qualification, and computer system validation methodology in accordance with GAMP 5.  Hands-on experience on qualification of analytical instrumentation such as, TOC analyzer, Vi-cell, Cary 50, Solo VPE, UV/VIS spectrophotometer, and other computerized instrumentation.  Role requires in depth working knowledge of current FDA Aseptic Process Guidance for Industry, solid background and experience with GMP’s, and hands-on experience with USP, EP and JP.  Experience improving and maintaining equipment, excellent project management, communication, and technical writing skills are also required.  The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

Education/Experience/ Licenses/Certifications\:

B.Sc, B.Eng in Biology, Chemistry or Chemical/Biochemical Engineering  with a minimum of 1-3 years relevant experience or a M. Sc in Biology, Chemistry or Chemical/Biochemical Engineering with 0-2 years relevant experience . Associates Degree with 4-6 years with relevant experience will be considered.  Bachelors and Masters preferred.

 

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.