Quality Assurance Validation Specialist

Position Summary

We are seeking an experienced Quality Assurance Validation Specialist to provide quality oversight for pharmaceutical and biopharmaceutical validation activities. Working within cross-functional project teams, this role will review and approve validation deliverables and change controls to ensure facilities, systems, equipment, and processes comply with regulatory requirements, company standards, and current industry practices.

The successful candidate will support validation across facilities, utilities, manufacturing equipment, instruments, process qualification, cleaning validation, computerized systems, data integrity, and other systems used in regulated pharmaceutical environments.

Key Responsibilities

• Review validation documents against approved Standard Operating Procedures (SOPs), regulatory requirements, and internal quality guidelines.
• Assess validation documentation for accuracy, completeness, consistency, and GMP compliance.
• Provide quality review and approval of documentation needed to support project execution and regulatory submissions.
• Review and approve validation lifecycle deliverables, including:
  • Validation Master Plans
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Computer System Validation (CSV)
  • Validation maintenance packages
  • System decommissioning documentation
• Provide validation expertise during the development or modification of manufacturing facilities, utilities, equipment, processes, information systems, and computerized systems.
• Define, communicate, and oversee applicable Quality Assurance requirements throughout the project lifecycle.
• Participate in project and system risk assessments.
• Ensure requirements remain traceable throughout the complete project lifecycle.
• Support the resolution of quality-related issues, including matters involving GMP requirements and validation compliance.
• Review change controls and evaluate their potential impact on validated systems and processes.
• Maintain project quality metrics and communicate risk trends, implementation readiness, and potential impacts to project timelines and commercial readiness.
• Collaborate effectively with Engineering, Manufacturing, Quality, Validation, Automation, IT, and other project stakeholders.
• Perform other related duties as assigned.

Qualifications

Education

• Bachelor’s degree in Biotechnology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related discipline.
• An advanced degree may be considered in combination with relevant professional experience.

Experience

• At least six years of experience in a pharmaceutical, biopharmaceutical, biotechnology, or related regulated manufacturing environment.
• Demonstrated experience in pharmaceutical or biotechnology validation.
• Hands-on experience writing, reviewing, and executing validation protocols.
• Experience reviewing qualification and validation documentation from a Quality Assurance perspective.
• Working knowledge of GMP regulations, data integrity principles, risk-based validation, and validation lifecycle practices.
• Experience with electronic document and validation management systems such as Veeva, Kneat, ALM, or comparable platforms.

Preferred Skills

• Strong understanding of facilities, utilities, manufacturing equipment, laboratory instruments, cleaning validation, process qualification, and computerized system validation.
• Familiarity with applicable FDA, EMA, ICH, GAMP 5, and other relevant regulatory or industry expectations.
• Strong technical writing and document-review capabilities.
• Excellent attention to detail, organization, and analytical judgment.
• Ability to identify compliance risks and communicate practical, risk-based recommendations.
• Strong interpersonal skills and the ability to work effectively with multidisciplinary teams.
• Ability to manage multiple priorities in a project-driven environment.

What Success Looks Like

In this position, you will help ensure that project deliverables are inspection-ready, validation requirements are traceable, risks are identified early, and new or modified systems are ready for compliant implementation and commercial use.