{"id":3680209,"url":"https://alion.io/job/curia-principal-validation-engineer","title":"Principal Validation Engineer","company":{"id":2070902,"name":"Curia","domain":"curiaglobal.com","url":"https://alion.io/company/curiaglobal","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"A","score":89,"open_postings":18,"ghost_share":0,"stale_share":0.444,"repost_share":0,"time_to_fill_p50_days":56,"computed_at":"2026-11-07T05:47:08Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Albuquerque, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-11-02T21:03:40Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-07T13:42:21Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Principal Validaiton Engineer, NPI in Albuquerque, NM\nBuild your future at Curia, where our work has the power to save lives\nCuria 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.\nWe proudly offer\nGenerous benefit options (eligible first day of employment)\nPaid training, vacation and holidays (vacation accrual begins on first day of employment)\nCareer advancement opportunities\nEducation reimbursement\n401K program with matching contributions\nLearning platform\nAnd more!\nAs 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.\nWorking 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.\nThe 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.\nThis 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.\nEssential Duties and Responsibilities:\nNPI and Technology Transfer Leadership\nServe as the senior Validation SME for assigned NPI and technology transfer programs.\nProvide strategic technical leadership for validation activities supporting new product introductions and commercial launches.\nParticipate as a core member of cross-functional Tech Transfer Teams from project initiation through commercial launch.\nLead validation assessments, fit-gap analyses, risk assessments and operational readiness reviews.\nDevelop validation strategies required to support technology transfer, process implementation and commercialization activities.\nProvide technical leadership during customer meetings, technical discussions, audits and governance reviews.\nPartner with Program Managers to identify project risks, mitigation strategies, resource requirements and critical path activities.\nDrive operational readiness activities necessary to support engineering studies, demonstration batches PPQ campaigns and commercial manufacturing.\nSupport knowledge transfer activities between sending and receiving organizations.\nParticipate in Technical Review Boards (TRBs), change management reviews and stage gate governance activities.\nValidation Strategy and Program Leadership\nProvide technical leadership for process validation, equipment qualification, utility qualification, sterilization validation, computerized systems validation, cleaning validation, facility qualification and aseptic process validation activities.\nDevelop and approve validation strategies, validation master plans, risk assessments, protocols, reports and lifecycle validation documentation supporting technology transfer and commercialization activities.\nEvaluate manufacturing processes and technology transfer documentation to determine validation requirements, critical process parameters (CPPs), critical quality attributes (CQAs) and validation acceptance criteria.\nLead complex technical investigations and provide expert guidance for validation-related deviations, change controls and CAPAs.\nEstablish and maintain validation standards, practices and governance frameworks supporting product commercialization activities.\nReview and approve validation documentation to ensure scientific soundness, regulatory compliance and alignment with customer requirements.\nSupport implementation of new technologies, equipment, manufacturing processes and digital systems from a validation perspective.\nEnsure validation activities comply with applicable regulatory expectations, industry standards, site procedures and customer commitments.\nRegulatory Compliance and Inspection Readiness\nServe as validation SME during regulatory inspections, customer audits and technical due diligence activities.\nSupport responses to validation-related observations, commitments and regulatory inquiries.\nMaintain current knowledge of global regulatory expectations, industry guidance documents and validation best practices.\nTechnical Leadership and Continuous Improvement\nMentor and provide technical guidance to validation engineers and cross-functional project teams.\nPromote standardization and continuous improvement of validation and technology transfer processes, tools and templates.\nCollaborate with Manufacturing, Quality, Regulatory Affairs, Technical Operations, Engineering, Microbiology and Analytical Sciences to resolve complex technical challenges.\nDevelop and deliver training related to validation strategy, technology transfer and operational readiness.\nRead and interpret SOPs and regulatory requirements to ensure compliance.\nMaintain required training qualifications.\nPerform other duties as assigned.\nEducation and/or Experience:\nRequired\nBachelor’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.\nOR\nMaster’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.\nPreferred\nNew Product Introduction (NPI) and technology transfer experience.\nProcess validation and cleaning validation program leadership.\nExperience supporting PPQ campaigns and commercial product launches.\nExperience with aseptic processing, sterilization validation, facility qualification and critical utility qualification.\nExperience interacting with customers and regulatory agencies.\nWorking knowledge of regulatory requirements, including FDA EU GMP, Annex1, Annex 11, PIC/S, ISPE, PDA and GAMP principles.\nSupervisory Responsibilities:\nThis role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.\nOther Skills and Abilities:\nProvides guidance and mentorship to team members\nFosters a collaborative and positive work environment\nChampions change\nPromotes 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.\nDemonstrates strong attention to detail\nExcellent communication skills, both verbal and written\nStrong technical writing skills are required to author validation documentation\nAbility to work semi-independently; demonstrate ability to interact well with other technical departments\nExcellent presentation and influencing skills and the ability to interact and gain the support of senior management\nExcellent leadership and collaboration skills in a cross-functional and fast paced environment\nAbility to organize time to successfully manage multiple projects and priorities\nAbility to read, understand, interpret and implement technical writing and instructions\nEffective interpersonal relation skills, while maintaining the adaptability to achieve company goals\nVerbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style\nOther Qualifications:\nMust pass a background check\nMust pass a drug screen\nMay be required to pass Occupational Health Screening\nMay be required to obtain and maintain gowning certification\nMay be required to obtain and maintain media qualification\nMay be required to wear a respirator\nEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.\nWe 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.\nAll 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. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 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