Quality Assurance Validation Engineer

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.

• 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.

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

• At least sixyears 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.

• 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.

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.