Engineer, IT Compliance

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

The Engineer IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. This role is primarily an individual contributor but may manage supporting contract resources periodically. The Engineer IT Compliance will partner with Quality Business Owners and Technical Owners to create and manage Quality Systems deliverables for electronic systems and applications throughout their lifecycle to ensure regulatory and procedural compliance supporting the sites right to operate.

Key Responsibilities:

• Manage department (IT) metrics reporting linked to regulatory compliance and Quality Events including Deviations CAPAs Change Requests Training and completion of applicable procedural requirements
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems
• Author / contribute content review and approve applicable Quality Systems records including Deviations CAPAs Change Requests SOPs and others as needed
• Partner with Quality and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
• Perform periodic reviews of applicable SOPs
• Participate in governance boards acting as the IT representative for regulatory and procedural compliance
• Support regulatory inspections as a subject matter expert (SME) as needed
• Manage supporting contract resources as needed
• Assist with site integration and enterprise harmonization activities as applicable

Working 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:

Bachelors degree in a life sciences engineering or technology discipline

or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.

Experience:

2 years of direct experience with Quality Systems (Deviations CAPAs Change Requests SOPs) related activities with a demonstrated understanding of electronic records / signatures and application of the ALCOA principles of data integrity

Strong knowledge of global Health Authority regulations current industry practices and experience with application of guidelines and regulations related to control of computerized systems electronic records and electronic signatures

Strong knowledge of Quality Systems records documentation and metrics reporting

Familiar with an array of computerized systems: MES ERP LIMS Validation Lifecycle / Testing Software QMS Learning Management System

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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