Senior Principal Validation Engineer in Albuquerque, NMBuild your future at Curia, where our work has the power to save lives.Curia 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.We proudly offer:Generous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!Summary:The 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.Essential Duties and Responsibilities:Develop and execute required protocols and complete reports for equipment, process utility, test, and revalidations as assigned.Develop and write standard operating procedures for new processes and equipment.Support department projects by assisting engineers, calibrations, and validations on ongoing projects.Support internal and external audits by providing and/or presenting data appropriate to the investigation as required.Keep department management and personnel aware of validation related issues that may have a regulatory compliance or financial impact.Responsible for providing leadership to the contractors supporting the validation program.Ensure change controls, records, and procedures follow current good manufacturing practices (cGMP) as well as good documentation practices (GDPs).Review and write validation protocols, final reports, and summaries of work for release of equipment tested.Serve as validation liaison between the site and customers or regulatory agencies during facility audits.Provide leadership and guidance to validation staff and contractors in the performance of their duties.Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report.Review and approve validation protocols for computer related systems (as needed), environmental monitoring (if applicable), process validations and cleaning validations.Coordinate 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.Write, update, approved, and maintain pertinent validation master plans for the facility.Ensure goals and objectives are met by contractors supporting validation of existing projectsParticipate in the review of changes made under the change control system from a validation perspectiveProvide validation oversight to facility, utility and equipment upgradesProvide validation input to technology transfersAuthor, review, or approve impact assessments prepared by the validation department for change controlsRead/interpret SOPs to ensure complianceMaintain up to date trainingsOther duties as assignedEducation and/or Experience:Bachelor's degree in science, engineering, or relevant field with a minimum of fifteen (15) years validation experience in pharmaceutical validation or aseptic/sterile product facilityORMaster's degree in science, engineering, or relevant field with thirteen (13) years validation experience in pharmaceutical validation or aseptic/sterile product facilityExperience with validation tools and processes, including temperature mapping and use of Kaye ValidatorExperience with FDA and EU regulations for pharmaceuticals and validation requirementsSupervisory Responsibilities:This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.Language Skills:The 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.Mathematical Skills:Proficient 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.Reasoning Ability:Ability 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.Computer Skills:The 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.Other Skills and Abilities:Provides guidance and mentorship to team membersFosters a collaborative and positive work environmentChampions changePromotes 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 detailExcellent communication skills, both verbal and writtenStrong technical writing skills are required to author validation documentationAbility to work semi-independently; demonstrate ability to interact well with other technical departmentsExcellent presentation and influencing skills and the ability to interact and gain the support of senior managementExcellent leadership and collaboration skills in a cross-functional and fast paced environmentAbility to organize time to successfully manage multiple projects and prioritiesAbility to read, understand, interpret and implement technical writing and instructionsEffective interpersonal relation skills, while maintaining the adaptability to achieve company goalsVerbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical styleOther Qualifications:Must pass a background checkMust pass a drug screenMay be required to pass occupational health screeningMay be required to obtain and maintain gowning certificationMay be required to obtain and maintain media qualificationMay be required to wear a respiratorPhysical Demands:The 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.The essential physical demands will vary for each Curia position.All 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,