Job Description
Principal Validaiton Engineer, NPI in Albuquerque, NM
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.
Essential Duties and Responsibilities:
NPI and Technology Transfer Leadership
• 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 manufacturing.
• Support knowledge transfer activities between sending and receiving organizations.
• Participate in Technical Review Boards (TRBs), change management reviews and stage gate governance activities.
Validation Strategy and Program Leadership
• Provide technical leadership for process validation, equipment qualification, utility qualification, sterilization validation, computerized systems validation, cleaning validation, facility qualification and aseptic process validation activities.
• Develop and approve validation strategies, validation master plans, risk assessments, protocols, reports and lifecycle validation documentation supporting technology transfer and commercialization activities.
• Evaluate manufacturing processes and technology transfer documentation to determine validation requirements, critical process parameters (CPPs), critical quality attributes (CQAs) and validation acceptance criteria.
• Lead complex technical investigations and provide expert guidance for validation-related deviations, change controls and CAPAs.
• Establish and maintain validation standards, practices and governance frameworks supporting product commercialization activities.
• Review and approve validation documentation to ensure scientific soundness, regulatory compliance and alignment with customer requirements.
• Support implementation of new technologies, equipment, manufacturing processes and digital systems from a validation perspective.
• Ensure validation activities comply with applicable regulatory expectations, industry standards, site procedures and customer commitments.
Regulatory Compliance and Inspection Readiness
• Serve as validation SME during regulatory inspections, customer audits and technical due diligence activities.
• Support responses to validation-related observations, commitments and regulatory inquiries.
• Maintain current knowledge of global regulatory expectations, industry guidance documents and validation best practices.
Technical Leadership and Continuous Improvement
• 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 with Manufacturing, Quality, Regulatory Affairs, Technical Operations, Engineering, Microbiology and Analytical Sciences to resolve complex technical challenges.
• Develop and deliver training related to validation strategy, technology transfer and operational readiness.
• Read and interpret SOPs and regulatory requirements to ensure compliance.
• Maintain required training qualifications.
• Perform other duties as assigned.
Education and/or Experience:
Required
• Bachelor's degree in Science, Engineering, or related technical discipline with a minimum of twelve (12) years of validation, technology transfer, manufacturing science or process engineering in a sterile pharmaceutical manufacturing environment.
OR
• Master's degree in Science, Engineering, or a related technical discipline with a minimum of ten (10) years of validation, technology transfer, manufacturing science or process engineering in a sterile pharmaceutical manufacturing environment.
Preferred
• 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, including FDA EU GMP, Annex1, Annex 11, PIC/S, ISPE, PDA and GAMP principles.
Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Other Skills and Abilities:
• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Excellent communication skills, both verbal and written
• Strong technical writing skills are required to author validation documentation
• Ability to work semi-independently; demonstrate ability to interact well with other technical departments
• Excellent presentation and influencing skills and the ability to interact and gain the support of senior management
• Excellent leadership and collaboration skills in a cross-functional and fast paced environment
• Ability to organize time to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions
• Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style
Other Qualifications:
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
May be required to obtain and maintain gowning certification
May be required to obtain and maintain media qualification
May be required to wear a respirator
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
