Job Information
Bristol Myers Squibb Senior Specialist, IT Validation -EMES in Hyderabad, India
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Job Title
Senior Specialist, IT Validation -EMES
Grade
EG110
Location
Hyderabad, India
Division
GPS IT
Direct Manager
Senior Manager CSV and PMO Leader, GPS-IT Hyderabad
Position Responsibilities
Development of Validation strategy, Validation Master Plans related to computer systems validation for Syncade.
Develop and review of Computer System Validation Artifacts including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Regression Testing, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOP's, Work Instructions.
Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation.
Ensure that the validation artifacts meet the quality requirements and applicable regulations FDA, EU, Corporate & International Standards.
Participate in Validation Cross Functional Teams at corporate and sites (Worldwide) to ensure adherence to required policies and procedures.
Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology.
Pre-approve and post-approve validation documentation and assessments from a quality perspective.
Provides CSV expertise and guidance related to management, peers, and lower-level professionals.
Lead the Validation team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training.
Participate in the Change Management process ensuring that all changes to validated computer systems are effectively assessed to ensure that regulatory compliance is maintained at all times.
Lead the Validation team in preparation for regulatory, internal, and corporate audits and inspections.
Represent Validation and BMS for audits and any corporate events (as required).
Report out to senior management on Validation status and metrics. Keep abreast of changing regulatory requirements, standards, and guidelines.
Mandatory Experience
Qualifications and Experiences:
The Senior Specialist, IT Validation -EMES should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline along with 10+ years' experience in pharmaceutical/ biopharmaceutical manufacturing facilities.
A strong background in computerized system validation and Manufacturing Execution Systems (MES).
Good technical understanding of IT Infrastructure, manufacturing execution systems (Syncade) and its integration with process automation systems (DeltaV), LIMS (Labware), SAP/Oracle.
Strong knowledge of regulatory validation requirements including FDA, EMA, and all other Worldwide Regulatory requirement.
Knowledge of FDA regulatory validation requirements including FDA (21CFR, part 11), EMA (Annex 11), GAMP and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9).
Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels.
Knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment.
Relevant experience with data integrity requirements and implementation in a GMP environment.
Knowledge of leading a successful team to project completion.
Problem solving ability and excellent oral and written communications skills.
Experience dealing with regulatory agencies and global audit teams.
Excellent communication skills and ability to influence others.
Skills Desired
Demonstrated success working in a matrix team structure to drive collaborative outcomes that meet organizational objectives.
Self-motivated with validated personal integrity, judgement and professional maturity and ability to collaborate.
Confirmed ability to use structured problem solving and available tools to quickly evaluate problems, identify root causes, create action plans, assess impact, and develop resolution options.
Demonstrated leadership ability to:
Empower and enable teams thrive in challenging situations, solving complex problems through innovative solutions.
Adapt to shifting priorities and dealing with ambiguity.
Influence scope and direction of initiatives across multiple organizational levels
Drive disciplined and effective decision making.
Anticipate risks/issues, assess, and solve problems, holding people accountable for outcomes.
Strong communicator via all media: collaboration technologies (SharePoint, MS Teams, etc.) and presentations written, emails, verbal - with a wide variety of audiences.
Excellent teamwork and interpersonal skills, with the ability to communicate and collaborate with employees and management at all levels.
#HYDIT #LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1579212
Updated: 2024-04-26 01:25:11.124 UTC
Location: Hyderabad-IND
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.