Manager, Quality Engineering in Devens, MA

Role Summary

The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA provides Quality oversight of qualification and validation activities and change control for startup and ongoing 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.

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 and maintain strong relationships with partner functions.

Qualifications

• Required: Ability to effectively communicate with team members.
• Required: Demonstrate strong interpersonal skills, regarding teamwork collaboration, verbal, and written communication.
• Required: Strong technical and problem-solving skills and the ability to work independently.
• Required: Knowledge of regulatory requirements, primarily cGMP, GxP, including 21CFR part 11, and good documentation practices.
• Required: 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.
• Required: Understanding of quality management systems.
• Preferred: Knowledge of applicable business systems including SAP, LIMS, Maximo and Veeva Vault is desirable.
• Preferred: Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable.

Education

• Bachelor's degree in a scientific or engineering discipline or its equivalent.