{"id":1929801,"url":"https://alion.io/job/curia-global-senior-principal-validation-engineer","title":"Senior 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":"B","score":78,"open_postings":20,"ghost_share":0,"stale_share":0.9,"repost_share":0,"time_to_fill_p50_days":36,"computed_at":"2026-11-05T05:54:30Z"}},"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":{"min_usd":78000,"max_usd":159000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1961},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2025-09-25T18:59:46Z","employer_posted_date":"2025-09-25","last_verified_at":"2026-11-05T02:51:41Z","board_verified":true,"closed_at":null,"days_open":405,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":405},"description":"Senior Principal Validation Engineer 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! \nSummary:\nThe Senior Principal Validation Engineer oversees Validation Contractors for the Albuquerque expansion and other key site projects. The majority of this role involves supervising relevant contractors at the Albuquerque site, including reviewing project proposals, interviewing, completing bid analysis, and selecting contractors. Responsibilities include managing projects and daily activities, overseeing validation activities, reviewing change controls, maintaining validated equipment, and updating validation documents such as the Validation Master Plan(s). Additional duties involve coordinating with departments to ensure timely completion of risk assessments, IQ, OQ, and PQ activities for new components, equipment, systems, and utilities, as well as developing and executing validation protocols for processes, equipment, utilities, and test systems. The role also supports new product introductions, equipment re-qualification schedules, and ensuring plant readiness post-shutdowns. The Senior Principal Validation Engineer will work with engineering, contractors, and facilities personnel to ensure proper system installation and operation, providing technical support for validated systems.\nEssential Duties and Responsibilities:\nDevelop and execute required protocols and complete reports for equipment, process utility, test, and revalidations as assigned. \nDevelop and write Standard Operating Procedures for new processes and equipment.\nSupport department projects by assisting engineers, calibrations, and validations on ongoing projects.\nSupport internal and external audits by providing and/or presenting data appropriate to the investigation as required. \nKeep Department Management and personnel aware of Validation related issues that may have a regulatory compliance or financial impact.\nResponsible for providing leadership to the contractors supporting the Validation program.\nEnsure change controls, records, and procedures follow current Good Manufacturing Practices (cGMP) as well as Good Documentation Practices (GDPs).\nReview and write validation protocols, final reports, and summaries of work for release of equipment tested.\nServe as validation liaison between the site and customers or regulatory agencies during facility audits.\nProvide leadership and guidance to validation staff and contractors in the performance of their duties.\nDevelop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.\nReview and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report.\nReview and approve validation protocols for computer related systems (as needed), environmental monitoring (if applicable), process validations and cleaning validations.\nCoordinate and prioritize validation activities for the facility, in particular for key projects, according project timelines to ensure timeliness and with minimal disruption of production schedules, as applicable.\nWrite, update, approved, and maintain pertinent Validation Master Plans for the facility.\nEnsure goals and objectives are met by contractors supporting Validation of existing projects\nParticipate in the review of changes made under the Change Control System from a validation perspective\nProvide validation oversight to facility, utility and equipment upgrades\nProvide validation input to technology transfers\nAuthor, review, or approve impact assessments prepared by the Validation Department for change controls\nRead/interpret SOPs to ensure compliance\nMaintain up to date trainings\nOther duties as assigned\nEducation and/or Experience:\nBachelor’s degree in Science, Engineering, or relevant field with a minimum of fifteen (15) years validation experience in pharmaceutical validation or aseptic/sterile product facility\nOR\nMaster’s degree in Science, Engineering, or relevant field with thirteen (13) years validation experience in pharmaceutical validation or aseptic/sterile product facility\nExperience with validation tools and processes, including temperature mapping and use of Kaye Validator\nExperience with FDA and EU regulations for pharmaceuticals and validation requirements\nSupervisory Responsibilities:\nThis role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.\nLanguage Skills:\nThe ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.\nMathematical Skills:\nProficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.\nReasoning Ability:\nAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.\nComputer Skills:\nThe ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.\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 \nThere may be other qualifications to add, ad hoc, such as the below:\nMay be required to obtain and maintain media qualification\nMay be required to wear a respirator\nPhysical Demands:\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nThe essential physical demands will vary for each Curia position.\nAll positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.\nWork Environment:\nThe work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nThe working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. \nThe office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. \nThe pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. \nThe warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. \nSome positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. \nAll environments may be subject to working with or being exposed to cleaning agents. \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. 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