Validation Specialist (Kneat / Digital Validation)

Job Description

Job Description

Pinnaql is 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.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

• 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.

This is a mid to senior level opportunity for someone who takes ownership, thrives in collaborative cross-functional settings, and is excited about shaping how validation is done. You're not just checking boxes on a validation protocol - you're someone who understands why each step matters and brings that rigor to everything you do. You communicate clearly, escalate early, and make the people around you better. You're comfortable operating in ambiguity and can juggle multiple priorities without losing quality.

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.

At Pinnaql, people always come first. 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.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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