Process Validation Engineer

Boston, MA, US • Posted 1 day ago • Updated 20 hours ago
Contract W2
On-site
$55 - $60/hr
Fitment

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Job Details

Skills

  • GxP
  • 21 CFR Part 11
  • CSV
  • ALCOA+
  • CAPA
  • FDA Audit
  • Veeva Vault

Summary

Job Title: Process Validation Engineer
Company: Prowise Solutions
Location: Boston, MA (Onsite 5 Days/Week)
Employment Type: W2 Only

Duration: 12 Months Contract with possible extension.

Rate: $55 to $60/hr on W2.

Job Description

Prowise Solutions is seeking an experienced Clinical Systems / GxP Compliance Consultant to support a leading client in the Pharma/Life Sciences domain. This role requires strong expertise in regulatory compliance and validation to ensure systems remain audit-ready and compliant with global standards.

Key Responsibilities

  • Maintain clinical and quality systems in a validated state
  • Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU Annex 11
  • Support FDA and regulatory audit readiness activities
  • Manage and oversee:
    • Change Controls
    • Deviations
    • CAPAs (Corrective and Preventive Actions)
    • Periodic Reviews
  • Apply ALCOA+ data integrity principles across systems and processes
  • Collaborate with cross-functional teams to ensure compliance and documentation standards

Required Qualifications

  • Prior experience in Pharmaceutical / Life Sciences industry
  • Strong understanding of:
    • GxP Compliance
    • 21 CFR Part 11
    • EU Annex 11
  • Hands-on experience maintaining validated systems
  • Experience with regulatory inspections and audit support
  • Strong documentation and communication skills
  • LinkedIn profile required
  • Ability to provide professional references upon request

Additional Requirements

  • Must be local to Massachusetts or willing to relocate
  • Comfortable working 5 days onsite in Boston, MA
  • Must be eligible to work on a W2 basis only

 

 

 

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10269444
  • Position Id: 8949762
  • Posted 1 day ago
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