Principal Validation Engineer

Curia • Albuquerque, NM

4d

About The Position

The Principal Validation Engineer serves as the senior Validation Subject Matter Expert on Curia’s New Product Introduction (NPI) Tech Transfer Team. The role provides strategic technical leadership for validation planning, qualification, operational readiness, and lifecycle validation activities required to introduce new products and technologies into a sterile pharmaceutical manufacturing facility. Working with Program Management, Manufacturing, Technical Operations, Quality, Regulatory Affairs, Engineering, customers, and other teams, the engineer develops and implements validation strategies that support technology transfer, regulatory compliance, and commercial manufacturing.

The position evaluates product, process, facility, equipment, and operational readiness requirements; develops validation strategies; leads risk assessments; resolves complex technical challenges; and ensures validation deliverables meet project timelines and customer expectations. The engineer represents Validation across multiple concurrent NPI programs and provides customer-facing technical leadership from project initiation through commercial launch.

The role requires advanced expertise in process, cleaning, equipment, utility, computerized systems, sterilization, aseptic process, and lifecycle validation in a sterile pharmaceutical manufacturing environment. It establishes approaches that support technology transfer, engineering studies, process performance qualification (PPQ), and commercial manufacturing while meeting applicable regulatory and quality requirements.

Requirements

• Bachelor’s degree in Science, Engineering, or a related technical discipline and at least 12 years of validation, technology transfer, manufacturing science, or process engineering experience in a sterile pharmaceutical manufacturing environment; or a master’s degree in one of these disciplines and at least 10 years of such experience.
• Advanced expertise in process validation, cleaning validation, equipment qualification, utility qualification, computerized systems validation, sterilization validation, aseptic process validation, and lifecycle validation in sterile pharmaceutical manufacturing.
• Ability to provide guidance and mentorship to team members and foster a collaborative, positive work environment.
• Ability to champion change and promote a safe and healthy work environment by identifying hazards, following safety protocols, participating in safety training, and fostering safety awareness.
• Strong attention to detail, verbal and written communication, and technical writing skills for validation documentation.
• Ability to work semi-independently and interact effectively with other technical departments.
• Excellent presentation and influencing skills, including the ability to gain senior management support.
• Strong leadership and collaboration skills in a cross-functional, fast-paced environment.
• Ability to manage time and successfully handle multiple projects and priorities.
• Ability to read, understand, interpret, and implement technical writing and instructions.
• Effective interpersonal skills and adaptability in achieving company goals.
• Ability to express ideas and facts clearly, logically, concisely, and with accepted grammatical style.
• Must pass a background check and drug screen.
• May be required to pass occupational health screening, obtain and maintain gowning certification and media qualification, and wear a respirator.

Nice To Haves

• New Product Introduction (NPI) and technology transfer experience.
• Process validation and cleaning validation program leadership.
• Experience supporting PPQ campaigns and commercial product launches.
• Experience with aseptic processing, sterilization validation, facility qualification, and critical utility qualification.
• Experience interacting with customers and regulatory agencies.
• Working knowledge of regulatory requirements and guidance, including FDA, EU GMP, Annex 1, Annex 11, PIC/S, ISPE, PDA, and GAMP principles.

Responsibilities

• 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 for technology transfer, process implementation, and commercialization.
• 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 for engineering studies, demonstration batches, PPQ campaigns, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations.
• Participate in Technical Review Boards, change management reviews, and stage-gate governance activities.
• Provide technical leadership for process, equipment, utility, sterilization, computerized systems, cleaning, facility, and aseptic process validation.
• Develop and approve validation strategies, validation master plans, risk assessments, protocols, reports, and lifecycle validation documentation.
• Evaluate manufacturing processes and technology transfer documentation to determine validation requirements, CPPs, CQAs, and acceptance criteria.
• Lead complex technical investigations and provide expert guidance on validation-related deviations, change controls, and CAPAs.
• Establish and maintain validation standards, practices, and governance frameworks for product commercialization.
• Review and approve validation documentation for scientific soundness, regulatory compliance, and alignment with customer requirements.
• Support new technologies, equipment, manufacturing processes, and digital systems from a validation perspective.
• Ensure validation activities comply with regulatory expectations, industry standards, site procedures, and customer commitments.
• Serve as the validation SME during regulatory inspections, customer audits, and technical due diligence.
• Support responses to validation-related observations, commitments, and regulatory inquiries.
• Maintain current knowledge of global regulatory expectations, industry guidance, and validation best practices.
• Mentor and provide technical guidance to validation engineers and cross-functional project teams.
• Promote standardization and continuous improvement of validation and technology transfer processes, tools, and templates.
• Collaborate across Manufacturing, Quality, Regulatory Affairs, Technical Operations, Engineering, Microbiology, and Analytical Sciences to resolve technical challenges.
• Develop and deliver training on validation strategy, technology transfer, and operational readiness.
• Read and interpret SOPs and regulatory requirements to ensure compliance, maintain required training qualifications, and perform other duties as assigned.

Benefits

• Generous benefit options, available from the first day of employment to eligible employees.
• 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: Principal