Principal Validation Engineer

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

As a member of the New Product Introduction (NPI) Tech Transfer Team, the NPI Principal Engineer serves as the senior Validation Subject Matter Expert (SME) for complex technology transfer and commercialization programs. This role provides strategic technical leadership for validation planning, qualification activities, operational readiness and lifecycle validation activities required to successfully introduce new products and technologies into the facility.

Working as part of a cross‑functional NPI team, the NPI Principal Validation Engineer partners with Program Management, Manufacturing, Technical Operations, Quality, Regulatory Affairs, Engineering and customers to develop and implement validation strategies that support technology transfer milestones, regulatory compliance and successful commercial manufacturing.

The position is responsible for evaluating product, process, facility, equipment and operational readiness requirements; developing validation strategies; leading risk assessments; resolving complex technical challenges; and ensuring validation deliverables are executed in accordance with project timelines and customer expectations. This role serves as the senior Validation representative for multiple concurrent NPI programs and provides direct customer‑facing technical leadership throughout the product lifecycle from project initiation through commercial launch.

This position requires advanced expertise in process validation, cleaning validation, equipment qualification, utility qualification, computerized systems validation, sterilization validation, aseptic process validation, and lifecycle validation principles within a sterile pharmaceutical manufacturing environment. The role is responsible for establishing validation approaches that support technology transfer, engineering studies, process performance qualification (PPQ), and commercial manufacturing while ensuring compliance with applicable regulatory and quality requirements.

• Serve as the senior Validation SME for assigned NPI and technology transfer programs.
• Provide strategic technical leadership for validation activities supporting new product introductions and commercial launches.
• Participate as a core member of cross‑functional Tech Transfer Teams from project initiation through commercial launch.
• Lead validation assessments, fit‑gap analyses, risk assessments and operational readiness reviews.
• Develop validation strategies required to support technology transfer, process implementation and commercialization activities.
• Provide technical leadership during customer meetings, technical discussions, audits and governance reviews.
• Partner with Program Managers to identify project risks, mitigation strategies, resource requirements and critical path activities.
• Drive operational readiness activities necessary to support engineering studies, demonstration batches PPQ campaigns and commercial…