6441 - CSV Engineer / Validation Engineer

Verista, Inc.Devens, MA
$70,491 - $113,521Onsite

About The Position

Verista is seeking a Validation Engineer to manage document and data control for the C&Q team. This role involves overseeing the repository structure, ValGenesis entity/document routing, Autodesk Forma turnover documentation, review/approval tracking, executed record quality, and closeout readiness. Verista is a company with 500 experts that collaborates with recognizable brands in the life science industry to address their business needs, focusing on empowering growth and innovation within the scientific community and helping solve healthcare challenges. The company emphasizes a people-focused culture, client success, integrity, inclusivity, and continuous learning.

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.

Nice To Haves

  • ValGenesis strongly preferred
  • Autodesk Forma or construction turnover tool experience

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.

Benefits

  • 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
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
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