Employment Type : Full-Time
Job Opening for Validation Engineer, Syracuse, NY : Client: Bristol Myer Squibb
We are currently working on below mentioned job opening i., e. Job Opening for Validation Engineer, Syracuse, NY : Client: Bristol Myer Squibb. Please let me know if you are interested in applying for the same.
Client: BMS
Onsite role/hybrid
Rate: $45/hr
Duration: 12+ months
POSITION SUMMARY: Reporting to the Validation Associate Director, the Analytical Validation Engineer will coordinate with the Network Quality Control Instrument Lifecycle Team, the local Quality and Microbiological Laboratories, Project Engineering and various network teams including Manufacturing Science and Technology (MST) as needed to manage the implementation and upgrades for computerized and non-computerized analytical systems and instrumentation.
The Analytical Validation Scientist / Engineer will be responsible to plan, manage, and execute the start-up, commissioning, validation and qualification of new analytical instrumentation and systems, complete validation impact assessments for projects and develop and maintain validation master/project plans. The Analytical Validation Scientist / Engineer will lead and/or coach junior scientists, laboratory analysts and contractors as needed as well as provide technical expertise for project stakeholders and cross-functional teams and support network led validation projects as part of the Network QC Validation team.
Duties/Responsibilities: (describe the most critical responsibilities/accountabilities of this position)
1. Develop Computerized Laboratory Instrument Validation and Qualification documentation including, Validation Plans, User and Functional Requirement Specifications (URS/FRS), Risk Assessments, Design Qualification (DQ) Protocols, Installation and Operational Qualification Protocols (IQ/OQ), Performance Qualification (PQ) Protocols, Traceability Matrices, Configuration Specifications, and Validation Summary Reports.
2. Develop Qualification documentation for non-computerized systems.
3. Work closely with laboratory Subject Matter Experts (SME) to solve technical problems, identify worse case scenarios, and gain insight into the specific use of each instrument subject to qualification activities.
4. Support Network Quality Control (NQC) Instrument Lifecycle Team in executing network led qualification projects.
5. Drive the completion of qualification activities onsite while working with cross-functional teams.
6. Track validation project schedules and milestones.
7. Communicate progress effectively and escalate technical and logistical concerns promptly.
8. Maintain familiarity and current knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) for the major tests run in the QC and Microbiological Control (MC) Laboratories.
9. Support Instrument Comparability Studies with MST and laboratory qualification and implementation teams.
10. Review vendor supplied qualification protocols for technical content ensuring the protocols meet BMS and Regulatory requirements.
11. Maintain safe working environment throughout the implementation and qualification process.
12. Follow company policies and procedures throughout the implementation and qualification process.
13. Operate instrumentation during installation and operational qualifications.
14. Record/review data using good documentation practices.
15. Conduct investigations as required.
16. Support Validation Services and NQC activities by writing, revising, or reviewing SOPs, training materials and change requests.
17. Serve as SME during regulatory and internal inspections and ensuring timely completion of requests generated during them.
18. Maintain familiarity with BMS directives and industry guidelines on validation.
19. Evaluate and assess change controls request and make recommendation following validation services SOPs.
20. Serve as Validation Services designee as directed when training and qualifications are appropriate.
21. Support validation department activities to maintain proper documentation storage and database system