Engineer, IT Compliance, Lab and Quality Systems

Bristol Myers Squibb • Devens, MA

13d

About The Position

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.

Requirements

• 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.
• 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.

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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees