Senior Validation Engineer – Veeva Validation Management

Senior Validation Specialist – Veeva Validation Management (Must Have)

Location: Rockville, Maryland

Job Type: Full-Time Contract

Work Schedule: 100% Onsite

About the Role

We are seeking an experienced Senior Validation Specialist to support a major pharmaceutical manufacturing project in Rockville, Maryland. This position will play a critical role in implementing and supporting Veeva Validation Management (GVLMS) while ensuring compliance with GMP regulations and validation lifecycle requirements.

This is an excellent opportunity for professionals with strong pharmaceutical validation experience who enjoy working in a highly regulated GMP manufacturing environment.

MUST HAVE REQUIREMENTHands-on experience with Veeva Validation Management is REQUIRED.

Candidates without direct experience using Veeva Validation Management for validation lifecycle activities will not be considered.

Key Responsibilities

• Support implementation of Veeva Validation Management (GVLMS).
• Create, review, revise, and maintain validation documentation.
• Author and update Validation Master Plans (VMPs), SOPs, validation templates, and engineering procedures.
• Manage validation documentation within the Veeva Vault environment.
• Route documents through electronic approval workflows.
• Ensure compliance with FDA regulations and 21 CFR Part 11 requirements.
• Support qualification lifecycle activities including IQ, OQ, PQ, and periodic reviews.
• Assist with validation document digitization and electronic document management.
• Maintain validation records and traceability documentation.
• Support change control activities and validation project tracking.
• Collaborate with Quality, Engineering, Manufacturing, Validation, and Technical Operations teams.
• Prepare project status reports and documentation while maintaining GMP compliance.

Required Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Chemistry, or related discipline.
• Minimum 5 years of pharmaceutical, biotechnology, or GMP validation experience.
• Direct hands-on experience with Veeva Validation Management (REQUIRED).
• Experience working within Veeva Vault.
• Experience authoring validation documentation including:
• Validation Master Plans (VMP)
• SOPs
• Validation Protocols
• Validation Reports
• Guidance Documents
• Strong knowledge of:
• GMP
• GAMP 5
• FDA regulations
• 21 CFR Part 11
• ALCOA+ Data Integrity
• Experience with Change Control.
• Excellent technical writing and documentation skills.
• Ability to work effectively with cross-functional teams.

Preferred Qualifications

• Cell Therapy or Biologics manufacturing experience.
• Experience supporting digital validation platform implementations.
• Experience with SAP PM.
• Experience with validation lifecycle management systems.

Pay: $60.78 - $67.96 per hour

Work Location: In person