Engineer Computer System Validation CSV
Engineer Computer System Validation CSV
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team at Devens Cell Therapy Facility. The CSV Engineer will be responsible for ensuring that all computer systems and software used in our manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves the development and maintenance of validation protocols and documentation to support the validation lifecycle of GxP systems.
Key Responsibilities:
Develop and execute validation plans protocols (IQ OQ PQ) and reports for computer systems and software applications used in GxP environments.
Ensure compliance with regulatory requirements (FDA EMA etc. and industry standards (GAMP 5 21 CFR Part 11 etc..
Collaborate with crossfunctional teams including IT Manufacturing Sciences and Technology Quality Assurance Manufacturing and Laboratory to ensure successful validation of systems.
Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
Maintain validation documentation and ensure it is uptodate and readily available for audits and inspections.
Participate in the review and approval of system change controls deviations and CAPAs related to computer systems.
Provide training and guidance to stakeholders on CSV processes and best practices.
Stay current with industry trends and regulatory updates related to computer system validation.
Qualifications:
Bachelors degree in Computer Science Engineering Life Sciences or a related field.
Minimum of 2 years of experience in computer system validation within the pharmaceutical biotechnology or medical device industry.
Strong knowledge of regulatory requirements and industry standards related to CSV (e.g. FDA EMA GAMP 5 21 CFR Part 11.
Experience with validation of various types of systems including MES DeltaV LIMS ERP and laboratory instruments.
Excellent written and verbal communication skills with the ability to create clear and concise validation documentation.
Strong analytical and problemsolving skills with attention to detail.
Ability to work independently and as part of a team in a fastpaced environment.
Proficiency in Microsoft Office Suite and validation software tools.
Preferred Qualifications:
Advanced degree in a related field.
Experience with cloudbased systems and software as a service (SaaS) validation.
Knowledge of data integrity principles and practices.
Certification in computer system validation or related areas (e.g. ASQ ISPE).
Working Conditions:
Office and laboratory environment.
Occasional travel may be required to support validation activities and workshops at other sites.
If you come across a role that intrigues you but doesnt 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 Lifechanging 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.
Onsite Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Employment Type
Full-Time
