Job Description

Lead Computer System Validation (Csv) Engineer

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. 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.

At Bristol Myers Squibb we are reimagining the future of Cell Therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Lead Computer System Validation (CSV) Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Shifts Available:

Monday to Friday

• 8 a.m. to 5 p.m.

Responsibilities:

• Supports equipment qualification and validation activities.
• Investigate and resolve Deviations, CAPA investigations and other potential issues.
• Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11.
• Supports the execution of equipment qualifications and validation protocols.
• Supervises vendors for qualification functions.
• Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
• Initiates, manages, and leads projects of moderate scope and complexity within their functional area.
• Manages projects of varying scope and complexity.
• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
• Author quality procedures and training documents.
• Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners.
• Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Support growing standardization efforts in the review and approval of Validation Deliverables.
• Promotes and provides excellent customer service and support.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues.
• Interfaces with customers to ensure all expectations are being met.
• Ensure equipment, facilities and programs are maintained in compliance.

Knowledge & Skills:

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Strong working knowledge of SDLC principles and standards.
• Ability to work with the end user to identify and document User and Functional Requirements.
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience executing equipment qualification documents.
• Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups.
• Strong working knowledge of MS Windows client and server technologies.
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Strong written and verbal communication skills along solid presentation skills.
• Proficient at writing well-formulated emails and reports.
• Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
• Ability to effectively communicate with employees, contractors, and vendors.
• Experience with technical writing and document development / generation.
• Strong computer skills in Microsoft Office Suite Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Basic Requirements:

• BS degree or equivalent experience.
• Minimum 5 years of experience in FDA-regulated industry.

Working Conditions:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
• Primarily an office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

The starting compensation for this job is a range from $86,490 - $104,800, 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 where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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 a supportive culture, promoting global participation 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 an 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

Bristol Myers Squibb

Job Tags

Temporary work, For contractors, Summer work, Work at office, Immediate start, Remote work, Shift work, Monday to Friday,

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