Manager, Quality Engineering in Devens, MA

Bristol Myers Squibb • Devens, MA

73d • $105,450 - $127,782

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. Shifts Available: Monday – Friday, standard working hours.

Requirements

• 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.

Nice To Haves

• Knowledge of regulatory requirements, primarily cGMP, GxP, including 21CFR part 11, and good documentation practices.
• Understanding of quality management systems.
• Knowledge of applicable business systems including SAP, LIMS, Maximo and Veeva Vault.
• Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV.

Responsibilities

• Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities.
• Review and approve computer systems validation lifecycle documentation associated with manufacturing site, standalone and site based computerized systems.
• 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.
• 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

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees