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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

Purpose and Scope of Position

The Validation Engineer supports the successful implementation of equipment/utilities/facility/lab instruments at multi-use sites through interaction with internal customers and external service providers.

The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.

The individual participates in projects and ongoing work activities of low to moderate complexity.

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.

Duties and Responsibilities:

Maintains qualified equipment systems in compliance with policies, guidelines and procedures:

• Develops qualification protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols.
• Supports equipment qualification and validation activities including Controlled Temperature Units (CTU) temperature mapping.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

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 equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
• Provides technical support and guidance on equipment and computer systems qualification and validations issues.
• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Regulatory Responsibilities

• Ensure equipment, facilities and programs are maintained in compliance.

Required Competencies: Knowledge/ Skills, and Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
• Proficient in CTU temperature mapping
• Strong knowledge of temperature mapping equipment and software.
• Experience in the qualification of cell therapy equipment a plus
• Knowledge of pharmaceutical, manufacturing and laboratory systems
• Strong written and verbal communication skills
• Excellent interpersonal skills with experience dealing with a diverse workforce
• Strong multi‐tasking ability in conjunction with proven organizational skills. 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
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business

Education and Experience:

• BS in Engineering or Science related discipline preferred
• Minimum of 2 years’ experience performing/supporting activities in a GMP environment
• Minimum of 2 years’ experience in equipment, facility or utility qualification

Working Conditions:

• Primarily office based, but some on floor/clean room interactions may be required
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions
• Reagents, chemicals, and exposure to sanitization agents could be expected
• Potential exposure to human blood components and strong magnets
• Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum

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.

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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.

On-site Protocol
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.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.