Senior Specialist

Role Summary

Senior Specialist, Quality Engineering. The role provides quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. Based in Devens, MA, the Senior Specialist will lead quality oversight, participate in risk assessments and data integrity assessments, support inspections, and drive continuous improvement across the function.

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, and requalification.
• 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, 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 the function at cross-functional meetings. Share data/knowledge within and across teams. Build and maintain strong relationships with partner functions.

Qualifications

• 4+ years of experience in a regulated industry with 1+ year experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic validation documentation systems.

Education

• Bachelor's degree in STEM field preferred. High school diploma/Associates degree with equivalent combination of education and work experience may be considered.

Skills

• 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 and 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

Additional Requirements

• Site-essential roles require 100% of shifts onsite at your assigned facility.
• Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
• For field-based and remote-by-design roles, the ability to travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.