6441 - CSV Engineer / Validation Engineer

Verista•Devens, MA

5d•Onsite

About The Position

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. This role is seeking a Validation Engineer to own document and data control for the C&Q team, including repository structure, ValGenesis entity/document routing, Autodesk Forma turnover documentation, review/approval tracking, executed record quality, and closeout readiness.

Requirements

Bachelor’s Degree or equivalent required
5-10+ years GMP document control or validation document management
ValGenesis strongly preferred
Autodesk Forma or construction turnover tool experience
GDP and electronic records fluency
Knowledge of GMP documentation standards and electronic quality management systems
Excellent organizational and communication skills
Ability to be on-site, full-time in Devens, MA

Responsibilities

Build and maintain document trackers covering system requirements, SLIA/SCA/BCA, DQ, QRA, ERES/data integrity, QP, configuration specifications, traceability matrices, commissioning documents, IOQ/PQ, QSR, green tag, and blue tag
Coordinate document templates, table-of-contents reviews, formal routing, comment incorporation, approval readiness, and final retrieval/closeout packages
Maintain distribution list, team roster, meeting minutes, action items, and document status dashboards for PM use
Track gaps between construction turnover packages, vendor documentation, commissioning evidence, and qualification records