6361 - Xuri/Single-Use Equipment SME / Senior Validation Engineer

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Job Overview: We are seeking a Xuri/Single-Use Equipment SME to support qualification of Xuri Cell Expansion System W25 units or similar single-use cell expansion equipment. This is the largest equipment workstream and includes Phase 1 and Phase 2 deliverables. The role will support vendor qualification execution with wrapper documentation, URS revisions, System Readiness Checklist revisions/executions, IOQ revisions/executions, PQ strategy/execution for new model units, and QSR completion. Senior Validation Engineer Responsibilities: Lead CQV strategy and execution support for Xuri / single-use cell expansion systems Coordinate vendor documentation and vendor qualification execution support Support wrapper execution strategy and documentation Author/revise URS, System Readiness Checklists, IOQ protocols, PQ documentation, and QSRs Support qualification planning for like-for-like units and new model units Provide technical guidance to CQV execution engineers Support discrepancy/deviation documentation and closure Coordinate with engineering, manufacturing, quality, CQV, and vendor teams Job Requirements: Bachelor’s Degree or equivalent required 8+ years CQV/validation experience in GMP manufacturing environments Experience qualifying process equipment, single-use systems, bioreactors, cell expansion systems, or similar GMP manufacturing equipment Experience with protocol authoring, execution, discrepancies/deviations, and QSRs Experience working with vendor documentation and vendor-supported qualification Xuri, WAVE bioreactor, single-use bioreactor, or cell therapy manufacturing experience Biologics manufacturing experience Experience supporting rapid GMP readiness timelines This role requires the ability to be on-site, full-time in Devens, MA. For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range

$80,465—$128,535 USD

Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com