Verista

6441 - CSV Engineer / Validation Engineer

Verista$70K — $113K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent required
  • 5-10+ years GMP document control or validation document management
  • Experience with ValGenesis strongly preferred
  • Familiarity with Autodesk Forma or other construction turnover tools
  • Proficient in GDP and electronic records
  • Knowledge of GMP documentation standards and electronic quality management systems
  • Excellent organizational and communication skills

Responsibilities

  • Build and maintain comprehensive document trackers for validation processes
  • Coordinate creation and approval of document templates and routing
  • Manage team communication tools, including meeting minutes and action items
  • Track discrepancies in construction turnover and qualification records
  • Ensure readiness for document closeout and retrieval packages

Benefits

  • High growth potential in a fast-paced, people-focused environment
  • Competitive pay with performance-based incentives
  • Company-covered life and disability insurance
  • Comprehensive medical, dental, and vision plans
  • Flexible Spending Accounts and commuter benefits
  • 401(k) with employer matching
  • Paid Time Off with rollover option
  • Tuition reimbursement programs
  • Engaging team social activities
  • Employee recognition programs
Full Job Description
Job Overview: We are 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.

Validation Engineer 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

Job 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

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.

National (US) Range

$70,491-$113,521 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

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Founded
2017

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