Bristol Myers Squibb
Manager, Quality Engineering in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Manager, Quality Engineering in Devens, MA
Join to apply for the
Manager, Quality Engineering in Devens, MA
role at
Bristol Myers Squibb
Overview
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
Responsibilities
Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities, equipment, and utilities, including system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification, and related activities.
Review and approve computer systems validation lifecycle documentation associated with manufacturing site, standalone and site-based computerized systems, including system classification, user requirements, functional specifications, installation qualification, operational qualification (system testing), user acceptance testing, performance qualification, periodic review, and related activities.
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 the assigned learning plan.
Support integration of newer team members.
Lead meetings and represent the function at cross-functional meetings. Share data and knowledge within and across the team. Build and maintain strong relationships with partner functions.
Knowledge, Skills, Abilities
Ability to effectively communicate with team members.
Strong interpersonal skills, 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.
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 applicable business systems including SAP, LIMS, Maximo and Veeva Vault is desirable.
Knowledge of manufacturing execution systems such as Syncade and distribution control systems such as DeltaV is desirable.
Basic 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 (e.g., equipment qualification, computer system validation, analytical equipment/method validation, or process validation).
Compensation Overview Devens, MA – US $105,450 – $127,782 (base salary range)
Additional incentive cash and stock opportunities may be available based on eligibility.
Equal Employment Opportunity BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and ongoing support. Our Equal Employment Opportunity statement is available for review at our careers website.
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Manager, Quality Engineering in Devens, MA
role at
Bristol Myers Squibb
Overview
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
Responsibilities
Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities, equipment, and utilities, including system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification, and related activities.
Review and approve computer systems validation lifecycle documentation associated with manufacturing site, standalone and site-based computerized systems, including system classification, user requirements, functional specifications, installation qualification, operational qualification (system testing), user acceptance testing, performance qualification, periodic review, and related activities.
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 the assigned learning plan.
Support integration of newer team members.
Lead meetings and represent the function at cross-functional meetings. Share data and knowledge within and across the team. Build and maintain strong relationships with partner functions.
Knowledge, Skills, Abilities
Ability to effectively communicate with team members.
Strong interpersonal skills, 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.
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 applicable business systems including SAP, LIMS, Maximo and Veeva Vault is desirable.
Knowledge of manufacturing execution systems such as Syncade and distribution control systems such as DeltaV is desirable.
Basic 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 (e.g., equipment qualification, computer system validation, analytical equipment/method validation, or process validation).
Compensation Overview Devens, MA – US $105,450 – $127,782 (base salary range)
Additional incentive cash and stock opportunities may be available based on eligibility.
Equal Employment Opportunity BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and ongoing support. Our Equal Employment Opportunity statement is available for review at our careers website.
#J-18808-Ljbffr