CSV Systems Engineer III

CSV Systems Engineer III in Albuquerque, NMCuria provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.TheCSV Systems Engineer III is an integral part of the Curia Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems Engineer III will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections.Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.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 programLearning platformAnd more!Supervisory Responsibilities:This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.Essential Duties and Responsibilities:The main duty of the CSV Systems Engineer III is to ensure that routine tasks related to validating electronic systems and applications used in commercial drug product manufacturing are documented in compliance with company procedures and health authority regulations.Generate and execute validation documents, to ensure the system(s)/software are maintained in the most current validated state per regulatory requirementsAssist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipmentAssist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessmentsPerform gap assessments on vendor executed protocols, ensuring compliance to current regulations are met and maintainedCollaborate across functional areas across the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processesProvide guidance/support during specification (URS, FS, DDS or CS) document generation and reviewShall ensure that all required Software/System Development Lifecycle Documents are available for regulatory and client audits, and participate as needed in site audits.Develop and execute CSV change records (Change Controls), CAPAs and Quality events for CSV projectsAct as investigator on any CSV DeviationsSupport Site CSV actions resulting from client/regulatory auditsParticipate as site SME in site audits /inspectionsProvide guidance on quality issues that affect the integrity of data or system validationMaintain accurate inventory of all applications, hardware, and computer systems within the Curia Albuquerque siteEnsure all computer systems have up to date Antivirus software and backup software installationUpdate computer systems that are running outdated Operating systemsInvestigate failed backups and investigationsExecute periodic reviewsProvide routine project status reportsProvide routine software and hardware inventory updatesProvide routine progress updates on SOPs and TemplatesProvide CAPA, QE and CR updates to compliance teamProvide routine audit observations and remediationAbility to work at elevated heightsRead/interpret SOPs to ensure complianceMaintain up to date trainingsOther duties as assignedEducation and Experience:Bachelor’s degree in Engineering, Life Science, Information Technology or related fieldMinimum of five (5) years’ relevant experience working in a cGMP regulated industry specific to computer systems validationValidation experience in a cGMP quality control laboratory or sterile fill finish operations, developing and executing SDLC documents that meet current regulatory and industry expectation, preferred.Other 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 respiratorEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.Physical 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, 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.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. 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. Curia is an E-Verify employer.#LI-MM2