6362 - Analytical Instrument SME / Senior Validation Engineer

About the role

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 an Analytical Instrument SME / Senior Validation Engineer to support GMP qualification of analytical, lab, and controlled equipment. This role will support equipment such as incubators, freezers, fridges, tube sealers, CryoCart, and other lab or analytical support equipment. Senior Validation Engineer Responsibilities: Serve as analytical instrument / lab equipment SME for CQV deliverables Support URS revisions, System Readiness Checklists, IOQ protocols, PQ protocols, and QSRs Provide technical input for controlled temperature equipment qualification and mapping/PQ strategy Review vendor documentation and determine qualification impact Support protocol execution and discrepancy/deviation resolution Ensure consistent qualification strategy across similar equipment families Partner with CQV Technical Lead, SMEs, quality, engineering, and operations Support early documentation generation to enable execution team ramp Job Requirements: Bachelor's Degree or equivalent required 8+ years validation/CQV experience in GMP pharmaceutical, biologics, or life sciences environments Direct experience qualifying analytical instruments, lab equipment, and/or controlled temperature units Experience authoring and executing URS, IQ/OQ, PQ, readiness checklists, and QSRs Strong technical writing and documentation review skills Ability to independently drive deliverables and support less senior CQV execution resources Experience with incubators, freezers, refrigerators, tube sealers, CryoCart, or similar lab/process support equipment Experience with temperature mapping tools and CTU qualification Experience in biologics or cell therapy manufacturing Experience with ValGenesis 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

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