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6361 - Xuri/Single-Use Equipment SME / Senior Validation Engineer
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$80k–$129k/yr
Full-time
bachelor degree
Performance-based incentive programs, Life Insurance, Short-Term Disability Insurance, Long-Term Disability Insurance, Medical Insurance, Dental Insurance
Posted 45d ago
~40 hrs/week
Responsibilities
Lead the CQV strategy and execution for Xuri and single-use cell expansion systems, including the authoring of URS, IOQ, and PQ documentation. Coordinate with vendors and cross-functional teams to ensure successful equipment qualification and GMP readiness.
Requirements
Requires a Bachelor's degree and over 8 years of CQV/validation experience within GMP manufacturing environments. Must have specific expertise in qualifying single-use systems, bioreactors, or cell therapy manufacturing equipment.
Full job description
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
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
A full-service approach to managing GxP across the product lifecycle.
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
Fishers, Indiana
LinkedIn followers
37,181
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
Offices: 9100 Fall View Dr, Fishers, Indiana 46037, US · 950 W Valley Rd, Suite 2400, Wayne, Pennsylvania 19087, US · 1 Technology Park Dr., Suite 1, Westford, Massachusetts 01886, US · 400 Concar Dr,, San Mateo, CA 94402, US
computer system validationCQVQMSautomation engineeringR&Dmachine vision 21 CFR Part 11lab systems & informaticsEnterprise ITpackaging
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