Manager, Quality Engineering

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV) and process validation per established local and global standards.

Requirements

• Ability to effectively communicate with team members
• Demonstrate strong interpersonal skills, regarding teamwork collaboration, verbal, and written communication.
• Strong technical and problem-solving skills and the ability to work independently.
• Knowledge of regulatory requirements, primarily cGMP, GxP, including 21CFR part 11, and good documentation practices.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.
• Understanding of quality management systems.
• Knowledge of science generally attained through studies resulting in a bachelor’s degree in a scientific or engineering discipline or its equivalent
• A minimum of 6 years’ experience in an environment governed by cGMPs, including at least 3 years of validation-related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation)

Nice To Haves

• Knowledge of applicable business systems including SAP, LIMS, Maximo and Veeva Vault is desirable
• Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable

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: Manager
• Number of Employees: 5,001-10,000 employees