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Sr.Engineer, Computer Systems Validation

Company: Disability Solutions
Location: Bothell
Posted on: July 2, 2024

Job Description:

Working with UsChallenging. 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: .The Computer Systems Validation (CSV) Sr.Engineer works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Sr.Engineer will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Sr. Engineer has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant BMS procedures and regulations. This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems. Key Responsibilities:

  • 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
  • Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
  • 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 routine CSV lifecycle activities (as required)
  • Other related duties as assignedWorking Conditions:
    • Work will be performed in a normal office environment (or remotely) as well as cell therapy manufacturing areas, server rooms, data closets and warehouses.
    • Must be able to don appropriate gowning for entering cell therapy manufacturing and testing areas in accordance with company procedures.
    • Normal office temperatures and lighting conditions will apply. Must be able to lift up to 25 pounds. Must be able to sit for extended periods. Must be able to stand for extended periods.This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.Education:Bachelor's degree in a life sciences, engineering, or technology discipline,or a minimum of 5 years of equivalent biotechnology or pharmaceutical industryexperience.Experience:
      • Bachelor's degree in a life sciences or engineering / IT 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, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
      • Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
      • Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
      • 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 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: 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 CareersWith 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 . Visit 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.

Keywords: Disability Solutions, Seattle , Sr.Engineer, Computer Systems Validation, IT / Software / Systems , Bothell, Washington

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