Engineer, Computer Systems Validation (CSV)
Bristol-Myers Squibb Company
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.
Hybrid position (50% on-site in Bothell, WA, USA). The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on ERP (SAP) and MES (Emerson) integrations and recipe functions. This role is an individual contributor with occasional oversight of contract resources on a project basis. The CSV Engineer partners with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems. The CSV Engineer has primary responsibilities to ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations. This includes leading computer system validation efforts for new system implementations and changes to existing systems as well as coordinating system validation assessments, periodic reviews and audit activities.
The position has the following requirements:
- Bachelor's degree in an IT / engineering discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement).
- 2+ years of direct experience with CSV activities with some projects including ERP system integrations (experience with SAP validations is preferable).
- strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
- Strong knowledge of global health authority regulations, current industry practices, and experience with the application of guidance related to control of computerized systems and electronic records / signatures.
- Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
- Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS.
- Experience in following CSV methodology for system evaluations, changes, and implementations.
- Ability to work independently.
- Experience implementing controls directly supporting Data Integrity efforts is a plus.
Primary Duties and Responsibilities:
- Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES), coordinating with the global system technology and validation teams.
- Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
- Author, review and/or approve applicable CSV documentation.
- Perform or oversee test script execution efforts, including defect management.
- Ensure validation test strategies align with internal procedures and requirements for intended use.
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
- Support health authority inspections as a subject matter expert (SME) for CSV lifecycle activities (as required).
- Other related duties as assigned.
The starting compensation for this job is a range from $75,000 - $95,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
For more on benefits, please visit: https://careers.bms.com/working-with-us
Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 firstname.lastname@example.org. 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.
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