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Bristol Myers Squibb

Engineer, IT Compliance, Lab and Quality Systems

Posted Yesterday
Be an Early Applicant
In-Office
Devens, MA
89K-108K Annually
Junior
In-Office
Devens, MA
89K-108K Annually
Junior
This role supports laboratory and manufacturing IT systems, ensuring data integrity and compliance, leading projects, and liaising with global teams.
The summary above was generated by AI

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. Read more: careers.bms.com/working-with-us.

Summary:

The overall focus of this resource will encompass the following: laboratory and manufacturing instrument PC support and application administration, local support and liaison for global laboratory and quality systems, and administrator for local laboratory and quality systems. The resource will integrate information from the end user and in collaboration with matrix teams within BMS to understand opportunities for investigating and implementation of existing and emerging technology in accordance with applicable regulations and BMS approved policies and procedures.

Responsibilities:

  • Execute, update, and support staff on documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.

  • Utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems with limited guidance and provide ownership of assets.

  • Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.

  • Provides digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defends their work before regulatory agencies.

  • Ensures alignment with BMS directives and industry guidelines for applications.

  • Execute on technology improvements and efficiencies opportunities to improve business and compliance.

  • Providing on-call support, as needed, for 24/7 commercial operations. 8. Support Quality and Manufacturing areas during audit and inspections from internal and external organizations

  • Work both independently and in a team environment at all levels of the organization, in particular Quality, Quality Control, and Manufacturing Operations.

  • Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

Knowledge and Skills:

  • Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.

  • Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.

  • Demonstrated leadership skills and the ability to negotiate in a complex environment.

  • Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.

  • Excellent verbal and written communication skills.

  • The ability to plan and lead small and medium size projects and enhancements.

  • Self-driven and capable of prioritizing.

  • Expanding understanding of network, databases, servers, and PCs.

  • Understanding of usage and administration of Waters NuGenesis.

  • Familiarity with Empower and one or more LIMS, LES/ELN and Document Management Systems. Management System and emerging technology is preferred.

  • Developed system and business analysis skills

  • Ability to apply lean and OpEx principles.

  • Project management, communication, and technical writing skills are required.

  • The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

  • Ability to sense, understand, and react to others emotions and recognize the impact of their emotions on your and other’s performance and behaviors.

Qualifications:

  • BS degree in life sciences, engineering or computer field or equivalent experience.

  • Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.

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.

Compensation Overview:

Devens - MA - US: $89,390 - $108,315

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

  • Health Coverage: Medical, pharmacy, dental, and vision care.

  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

  • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 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.

Supporting People with Disabilities

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1594158 : Engineer, IT Compliance, Lab and Quality Systems

Top Skills

Cgmps
Cyber Security
Document Management Systems
Eln
Empower
Gxp Compliance
Les
Lims
Software Development Life Cycle
Sops
Waters Nugenesis

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