Sr Quality Assurance Validation Engineer

VTI Life Sciences; Thousand Oaks (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

VTI Life Sciences in Thousand Oaks, CA is seeking an experienced Quality Assurance Validation Specialist to provide oversight for pharma and biopharma validation activities. This on-site role collaborates across projects to ensure facilities, equipment, and processes meet regulatory standards and company procedures.

Responsibilities include reviewing validation documents, overseeing lifecycle activities (DQ/IQ/OQ/PQ/CSV), maintaining data integrity, and ensuring traceability from design through

Qualifications

• Bachelor’s degree in biotechnology, microbiology, pharmacy, engineering, life sciences, or related field.
• An advanced degree may be considered with relevant professional experience.
• Minimum six years in pharmaceutical/biotech regulated environments.
• Experience writing, reviewing, and executing validation protocols.
• Familiarity with GMP, data integrity, risk-based validation.

Responsibilities

• Review validation documents against SOPs and regulatory requirements.
• Assess documentation for accuracy, completeness, GMP compliance.
• Provide QA review and approval of validation deliverables.
• Review lifecycle deliverables: MDPs, DQ, IQ, OQ, PQ, CSV.
• Support validation across facilities, utilities, equipment, processes.
• Maintain traceability of requirements through project lifecycle.
• Collaborate with engineering, manufacturing, QA, validation, IT.

Skills

GMP compliance

Data integrity

Validation lifecycle

Technical writing

Education

Biotechnology degree

Microbiology degree

Pharmacy degree

Engineering degree

Life Sciences degree

Tools

Veeva

Kneat

ALM

Job description

Quality Assurance Validation SpecialistPosition SummaryLocation: Thousand Oaks, California — On-site 40 Hours a week
Assignment Duration: August 2026 through February 2027
Extension Potential: Yes
Type of Role: Full Time Employment (W2) or Contractor
Industry: Pharmaceutical/Biotechnology
Experience Level:Intermmediate, with 6+ years of relevant experience

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, Analytical Method Qualification 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 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

Preferred Skills

• Strong understanding of Analytical Method Qualification, 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, native english 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.