Senior Validation Manager

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes.

Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Senior Validation Manager oversees all validation functions and collaborates with cross‑functional teams to lead computer systems validation, commissioning, qualification, and validation of facilities, utilities, and equipment necessary for manufacturing of novel engineered particles. This role is integral part of the Manufacturing Operations team partnering with Development, Manufacturing Sciences, and Quality Assurance teams to lead CQV and CSV activities for clinical and commercial production across Liquidia’s product portfolio throughout all stages of the product lifecycle across internal and manufacturing facilities.

• Guide and support the validation team to ensure that all projects are completed compliantly and on schedule.
• Represent validation cross‑functionally ensuring clear communication, providing strategy, and setting goals and objectives for the validation team.
• Project management skillset to remove roadblocks and communicate clearly across all parties/ teams.
• Responsible for qualification activities to ensure Liquidia’s facilities, utilities, and equipment are built, installed, and operate as intended throughout their lifecycle.
• Author or review user requirements, design specifications, or functional specifications.
• Lead or participate in risk assessments related to commissioning, qualification, and validation activities.
• Design and execute detailed master plans and protocols, author traceability matrices, and summarize results in technical reports.
• Support Computer Systems Validation ensuring compliance with FDA, 21
  
  CFR Part 11, Eudra Volume 4:
  Annex 11, and ISPE GAMP 5 guidelines.
• Data Integrity:
  Ensuring accuracy, completeness, and consistency of the data to comply with regulatory standards and industry best practices.
• Audit Support:
  Supporting internal audit readiness by providing necessary documentation and responding to audit inquiries.
• Carry out investigations related to protocol discrepancies or deviations.

• BS/MS/MEng in a technical discipline.
• A minimum of 10 years’ experience in commissioning, qualification, validation work, and CSV within FDA-regulated fields such as pharmaceuticals, biologics, or medical devices. Experience may include development, manufacturing, or quality.
• 3+ years of validation management experience required.

• Technical and management experience to lead a dynamic validation group that supports internal and external manufacturing.
• Demonstrated aptitude for “hands‑on” protocol execution across a wide range of equipment and systems.
• Experience with computerized system validation preferred.
• Mechanical aptitude and familiarity with production equipment, including automated systems.
• Experience with leading or supporting projects from late‑stage product development through commercial launch preferred.
• Working knowledge of quality management system elements, including change control, deviation management, and corrective and preventive actions.
• Ability to work and communicate effectively within a cross‑functional team and across levels within an organization.
• Ability to summarize data and results for business and technical audiences with excellent communication skills.

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP,…