Validation Engineer IV

Curia • Albuquerque, NM

6d • Onsite

About The Position

The Validation Engineer IV (NPI) is a senior-level professional and functional subject matter expert supporting New Product Introduction (NPI) and technology transfer activities at Curia’s Albuquerque, New Mexico site. As a dedicated, customer-facing member of the NPI Tech Transfer Team, the role provides technical leadership throughout the NPI lifecycle, supporting project planning, risk assessment, knowledge transfer, operational readiness, validation, and commercialization. The engineer works with Program Management, Operations, Quality, Regulatory, customers, and other functional teams to advance projects through tech transfer stage gates and meet site procedures, regulatory requirements, and customer expectations across multiple concurrent programs.

The role leads the development, review, and execution of complex validation protocols and provides technical guidance on equipment, processes, systems, and computer systems in accordance with cGMP, FDA regulations, and relevant industry standards. Validation activities may cover manufacturing and packaging equipment, sterilization systems, computerized systems, cleaning validation, cleanrooms, aseptic processing, critical utilities, lyophilizers, and other qualification needs. The engineer authors and approves validation master plans, protocols, and technical reports; coordinates validation work across departments; and supports production and quality timelines.

The position also supports regulatory inspections and audits, manages validation-related investigations and deviations, works with external vendors and consultants, and contributes to continuous improvement. It provides mentorship and technical training to junior and mid-level staff, and supports new product introductions, equipment requalification schedules, and plant readiness following shutdowns. The role has no formal supervisory responsibilities, although it may involve mentoring, guiding, and advising others.

Requirements

• Bachelor’s degree in science, engineering, or a relevant field and at least eight years of relevant pharmaceutical validation experience in an aseptic or sterile product environment; alternatively, a master’s degree in science, engineering, or a relevant field and at least six years of such experience.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator or Ellab Loggers.
• Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, GAMP 4 and 5 based on the GAMP V-Model Framework, and EU GMP Annex 11 for computer systems compliance.
• Strong attention to detail.
• Proficiency in advanced mathematics, such as calculus, and technical writing.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.
• Must obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.

Nice To Haves

• Experience with FDA and EU pharmaceutical regulations and validation requirements is preferred.

Responsibilities

• Act as the designated functional subject matter expert for assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews.
• Support development and execution of project plans, timelines, and deliverables for Tech Transfer stage gates.
• Provide technical expertise in customer meetings, technical discussions, audits, and governance reviews.
• Partner with Program Managers to identify project risks, mitigation plans, and escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed according to procedures and project timelines.
• Drive operational readiness for development, validation, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations, including process, product, analytical, and operational knowledge.
• Participate in Technical Review Boards, stage gate reviews, and leadership governance meetings.
• Collaborate with cross-functional departments to resolve technical challenges and remove execution barriers.
• Contribute to continuous improvement of NPI and Tech Transfer processes, tools, templates, and best practices.
• Lead development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification.
• Provide technical leadership for qualification and validation involving new product introductions, sterilization systems, computerized systems, cleaning validation, manufacturing and packaging equipment, cleanrooms, aseptic processing, and critical utilities such as water for injection and clean steam.
• Author, maintain, and approve validation master plans in compliance with applicable regulatory requirements and industry standards.
• Oversee and conduct validation testing, analyze data for accuracy, reliability, and compliance, and prepare final reports with recommendations for adjustments or corrective actions.
• Coordinate validation activities with production and quality teams to meet timelines and minimize disruption.
• Provide technical guidance and mentorship on equipment installations, system modifications, and validation practices to junior and mid-level validation staff.
• Manage relationships with external vendors and consultants supporting validation projects and ensure adherence to quality and compliance standards.
• Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations.
• Develop and deliver training on validation methodologies, regulatory expectations, and quality standards.
• Provide technical support for new product introductions, equipment, requalification schedules, and plant readiness after shutdowns.
• Read and interpret SOPs to ensure compliance and maintain up-to-date training.
• Promote a safe and healthy work environment by identifying hazards, following safety protocols, participating in safety training, and fostering safety awareness.
• Perform special projects and other duties as assigned.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior