Senior Specialist

Bristol Myers Squibb • Devens, MA

1d

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. Position Summary The Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Specialist, Quality Engineering is responsible for quality oversight.

Requirements

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
• Ability to interpret data & results, understand problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
• Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
• Ability to work in a fast-paced team environment and changing priorities.
• Detail oriented and task focused with ability to meet deadlines and prioritize work
• Able to work across functional groups and teams to ensure requirements are met
• Self motivated and contribute to a positive team environment
• Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
• Curious and ability to think critically to create innovative solutions
• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4+ years of experience in a regulated industry with 1+ year experience.
• Demonstrated experience with electronic validation documentation systems.

Nice To Haves

• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification etc.
• Review and approve computer systems validation lifecycle documentation associated with manufacturing site, standalone and site based computerized systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, periodic review, etc.
• May participate in and review/approve risk assessments, data integrity assessments, and technical reports supporting qualification
• Perform routine quality review/approval activities associated with equipment/system onboarding and status
• Identify improvement opportunities and support execution of team continuous improvement goals and projects
• May review and approve or provide impact assessment for site change controls
• Support internal and external inspections as required
• Maintain compliance with assigned learning plan
• Support integration of newer team members
• Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions.

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