Commissioning Qualification Specialist

Overview The BMS Devens Cell Therapy Manufacturing Site has been selected as the launch site of the new NEX‑T CD19 asset. The GoSolo program aims to design, build and deliver a robust, scalable end‑to‑end Automated Manufacturing System (AMS). The GoSolo AMS Commissioning and Qualification (C&Q) Lead will lead a team responsible for qualifying the automated system and supporting systems for delivery to BMS Devens operations. Required Competencies Degree in Engineering or Science related discipline (Life Science, Mechanical, Chemical); Engineering with Computer Science focus preferred. Approximately 10 years of relevant pharmaceutical industry experience focused on Cell and Gene Therapy application validation in a GMP environment. Approximately 10 years of experience managing personnel and/or complex projects, including direct experience managing diverse C&Q contractors for large projects. Extensive understanding of PLCs, SCADA, DCS, MES, and data integrity principles (e.g., 21 CFR Part 11, GAMP 5). Experience integrating automation systems in GMP environments. Familiarity with ASTM E2500 and risk‑based qualification approaches. Strong problem‑solving, verbal and written communication, and interpersonal skills; ability to work independently and influence across organizational boundaries. Project and change management experience; experience with Product Life Cycle Management. In‑depth knowledge of FDA, EMA, and ICH guidelines relevant to ATMPs, including Annex 11 and Annex 15. Duties and Responsibilities Provide oversight of the site commissioning and qualification organization for capital projects; lead and manage an experienced team of colleagues and contractors focused on C&Q activities. Ensure on‑time, within‑budget completion of the GoSolo AMS project C&Q work of major complexity. Drive commissioning and qualification activities according to client standards, site/global SOPs, and regulatory requirements. Coordinate approval of C&Q firm deliverables as defined in the project plan or Validation Project Plan. Manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Interface with multiple sites and functions (Facilities and Engineering, MS&T, end users, IT, QA, suppliers, contractors) to achieve predefined goals and provide technical guidance. Design and author the C&Q execution strategy (Validation Project Plan or C&Q plan), provide scientific rationale and acceptance criteria, and review/approve commissioning, validation/qualification protocols and reports. Conduct and assist in industry and regulatory research including research into FDA guidelines for qualified automated systems and processes; determine acceptance criteria and testing. Lead or support the GoSolo AMS project team, coordinate execution of C&Q, prepare project schedules, and present status to senior management and stakeholders. Lead or support completion of complex investigations, initiate change controls (assessing impact), and manage corrective action plans associated with C&Q activities. Lead or support implementation of structures, tools, and processes to manage C&Q activities. Participate as subject‑matter expert during internal and external audits, answering questions and reviewing qualifications with auditors. Site and Work Schedule 100% onsite. Work schedule: Monday‑Friday (normal business hours). Compensation and Benefits Starting hourly compensation range $58–$61.01/hr. This assignment is a contract assignment with ASK Staffing DBA ASK Consulting, providing services to Bristol Myer‑Squibb. Benefits: ACA‑compliant health coverage, dental, vision, short‑term and long‑term disability, commuter benefits, 401(k) plan (no matching), referral bonus program, unpaid leave, and paid sick leave as required by law. Equal Opportunity and Legal Notices ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws. ASK Consulting is committed to complying with the California Privacy Rights Act (CPRA) and all relevant data privacy laws. Applicants with disabilities may request a notice in an alternative format. Fair Chance Employment Notice: Background checks may be conducted in accordance with federal, state, and local Fair Chance ordinances and laws. Qualified applicants with arrest or conviction records may still be considered. #J-18808-Ljbffr