About this opportunity
VTI Life Sciences lists this Sr Quality Assurance Validation Engineer opportunity in thousand oaks, California. Review the employer’s description below for duties, qualifications and application requirements.
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
EducationBachelor’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.
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Worksite address
thousand oaks, CA, 91362, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.