Validation Associate

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Validation Associate

Boston, Massachusetts

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Full Time Temporary/Contract

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$ 55 - $ 66 per hour

Boston, Massachusetts

Full Time Temporary/Contract

$ 55 - $ 66 per hour

July 21, 2025

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Job ID: 1424544_1753129344

July 21, 2025

Job ID: 1424544_1753129344

Job Summary

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We are seeking a Validation Associate to join our biopharmaceutical client on a 12-month contract. This role is fully remote/EST hours.

Summary:

The Validation Associate will support the IT environment with oversight responsibilities by the our Client's Global Quality organization.

Key Responsibilities

  • Implementing the Data Integrity standards, policies and procedures within allocated areas of the business
  • Prior knowledge and experience in Validating SAP, Veeva, Pharmacovigilance systems.
  • Author and review of validation packages and gap assessment of such for deliverables received from vendors providing testing and validation of Apellis SaaS systems
  • Management of the validation life cycle
  • Review and management of the various validation projects supporting the GxP systems
  • Documentation, execution and review of testing required to meet the intended use of the system
  • Maintenance of the validation documents in a controlled environment and review at all times against inspection readiness compliant with 21 CFR Part 11, Annex 11 and other guidance and regulations supporting CSV
  • Management and execution of system periodic reviews
  • Coordinate with various functions, business owners and IT to maintain validated state of systems
  • Identify, plan and outline responsibilities for validation efforts across GxP systems
  • Provide risk and impact assessments as required for change control and system updates

Requirements

Education, Registration, Advance Training &/or Certifications:

  • Bachelor's degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.

Experience, Expert Knowledge &/or Competencies:

  • 7+ years related experience in Computer System Validation.
  • Knowledge of regulatory requirements and experience working in a GxP and CSV requirements
  • Hands on experience in authoring validation documents and associated procedures (SOPs)
  • Strong interpersonal verbal and documentation skills
1424544_1753129344

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™