Validation Specialist (Kneat / Digital Validation)
Job Summary
We are looking for an experienced Validation Specialist to lead and execute critical lab validation activities in a fast-paced, regulated environment. You'll work at the intersection of quality, technology, and compliance - leveraging digital platforms like Kneat to modernize and streamline validation workflows that directly support product safety and regulatory success.
Key Responsibilities
Lead and execute lab validation activities in alignment with project timelines and compliance requirements
Perform Commissioning, Qualification, and Validation (CQV) tasks across equipment and systems
Drive Computer System Validation (CSV) and Computer Software Assurance (CSA) activities
Author, review, and manage validation documentation using Kneat or equivalent digital validation platforms
Partner with cross-functional teams - Quality, Engineering, and IT - to ensure seamless validation execution
Ensure all validation deliverables meet applicable regulatory standards (FDA, GxP, and others)
Proactively identify, escalate, and resolve risks, deviations, and issues in validation processes
Champion continuous improvement initiatives for validation procedures and digital workflows
Required Qualifications
5+ years of validation experience in a regulated industry (pharma, biotech, medical devices, or similar)
Experience with CQV (Commissioning, Qualification, and Validation)
Experience with Computer Software Assurance (CSA) including risk-based approaches under FDA guidance
Experience with Computer System Validation (CSV) methodologies and lifecycle management
Proficiency with Kneat or comparable digital validation platforms
Deep understanding of GxP regulations and compliance requirements
Strong ability to manage validation documentation and lifecycle activities independently
Excellent analytical, communication, and problem-solving skills
Preferred Qualifications
Experience validating laboratory systems, instruments, and equipment
Familiarity with data integrity principles and regulatory expectations (e.g., ALCOA+)
Exposure to process improvement frameworks or digital transformation initiatives in validation
Experience working in a CRO, CDMO, or fast-scaling biotech environment
Strong analytical, communication, and problem-solving skills
About the Role
We are a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
Benefits
We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Pay
Competitive salary commensurate with experience.
Schedule
Hybrid work schedule available.