Validation Manager

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 ethics standards for the following position:

• Validation Manager

Position Overview

We are looking for a dedicated Validation Manager with extensive experience in Commissioning, Qualification & Validation (CQV) to oversee and lead validation projects. The Validation Manager will play a crucial role in ensuring compliance with regulatory requirements and Good Manufacturing Practices (GMP) throughout the product lifecycle.

This role requires strong technical documentation skills, attention to detail, and the ability to work collaboratively with Engineering, Quality, Manufacturing, Automation, and Project Management teams.

Key Responsibilities

• Lead and manage all Commissioning, Qualification & Validation (CQV) activities for pharmaceutical, biotechnology, medical device, and other regulated life sciences facilities.
• Develop and implement comprehensive validation strategies, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, and more.
• Direct the qualification of equipment, facilities, utilities, and manufacturing systems, ensuring adherence to standards and regulations.
• Supervise protocol execution, field verification, data collection, and review of qualification outcomes.
• Ensure all validation activities are conducted in strict compliance with GMP, FDA, EU GMP, and industry standards.
• Drive the application of risk-based validation methodologies, including participation in FMEA/risk assessments.
• Manage and oversee deviations, investigations, CAPA, and change control processes related to validation projects.
• Review engineering and technical documentation to guarantee validation requirements are fully addressed.
• Collaborate closely with Engineering, Quality Assurance, Manufacturing, Automation, and other stakeholders on projects.
• Monitor and track validation deliverables, schedules, open items, and project milestones effectively.
• Provide leadership in commissioning activities and ensure a seamless transition into formal qualification stages.
• Ensure all validation documentation is complete, accurate, and audit-ready, maintaining high-quality standards.
• Participate in client meetings, project status updates, and technical reviews to provide valuable input.
• Offer technical support during regulatory inspections and client audits as needed.

CQV Experience

Candidates should possess substantial hands-on experience in the commissioning and qualification of process equipment, facility and utility qualification, cleanrooms, HVAC systems, purified water/WFI systems, and more.

• Commissioning and qualification of process equipment
• Facility and utility qualification
• Cleanrooms and controlled environments
• HVAC systems
• Purified Water / WFI systems
• Compressed gases and process gases
• Autoclaves, sterilizers, and/or depyrogenation equipment
• Manufacturing and laboratory equipment
• Temperature-controlled systems
• Process systems and supporting utilities
• Equipment and system turnover documentation
• IQ/OQ/PQ execution

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• At least 5+ years of progressive experience in validation, qualification, commissioning, or CQV within a regulated life sciences environment.
• Extensive knowledge and understanding of GMP and validation principles.
• Proven experience in developing and executing validation and qualification protocols.
• Strong leadership, organizational, and project management skills.
• Exceptional ability to interpret engineering drawings, specifications, procedures, and technical documentation.
• Demonstrated success in working both independently and collaboratively in a project-oriented setting.

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.