Bristol-Myers Squibb
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.Position Summary Draft and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols. Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation. Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for the Cell Therapy function. Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups. Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors. Provides CSV expertise and guidance related to management, peers, and lower-level professionals. Key Responsibilities CSV Engineer within Leiden IT department. Responsible for compliance with local and global SOPs during qualification. Compliance with Project Change Management Procedure and PCM drafting, review and approval. Audit and Operational readiness for site. Change Management during qualification and sustaining. Other duties as assigned by Associate Director of IT Quality and Compliance. Qualifications & Experience Bachelors in Engineering, IT, Science field or equivalent Minimum 10+ year’s relevant industry experience. Prior Cell Therapy experience is highly valued but not required. Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment. Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians. Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP. Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements. Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices. Demonstrated success working in a high-performing, business results-driven environment. 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.
