Validation Engineer IV

Curia • Albuquerque, NM

5d

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 customer-facing member of the NPI Tech Transfer Team, the role supports multiple concurrent programs from project initiation through commercial launch, providing technical leadership, risk assessment, planning, execution support, knowledge transfer, and operational readiness. The position works closely with Program Management, Operations, Quality, Regulatory, and other functional teams to advance projects through technology-transfer stage gates and ensure compliance with site procedures, regulatory requirements, and customer expectations.

The role leads the development, review, and execution of complex validation protocols and provides technical expertise across equipment, processes, systems, and computer system validation. Areas of work include manufacturing and packaging equipment, sterilization systems, cleaning validation, cleanrooms, aseptic processing, critical utilities, and lyophilizers. The Validation Engineer IV authors and approves validation master plans, protocols, and technical reports; coordinates validation work across departments; supports investigations, deviations, inspections, and audits; and drives improvements to validation practices. The position also supports new product introductions, equipment and requalification schedules, and plant readiness following shutdowns. It may include mentoring and advising colleagues but has no supervisory responsibilities.

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 cGMP guidelines, GAMP 4 and 5 based on the GAMP V-Model Framework, and EU GMP Annex 11 for computer systems compliance.
• 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.
• Strong attention to detail.
• Proficiency in advanced mathematics, such as calculus, and technical writing.
• Ability to provide guidance and mentorship, foster a collaborative and positive work environment, champion change, and promote a safe and healthy work environment.

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 required 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 in accordance with established procedures and project timelines.
• Drive operational readiness activities required to support development, validation, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations, including transfer of 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 of new product introductions, sterilization systems, computerized systems, cleaning processes, manufacturing and packaging equipment, cleanrooms, aseptic processing operations, and critical utilities such as water for injection and clean steam.
• Author, maintain, and approve validation master plans in compliance with 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 with minimal disruption.
• Provide technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid-level 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 technical 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.
• Perform additional duties and special projects as assigned to support departmental and organizational objectives.

Benefits

• Generous benefit options, available 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