Current jobs related to Lead Computer Systems Validation Engineer - Albuquerque, New Mexico - Curia, Inc.

  • Senior Validation Engineer

    3 weeks ago

    Albuquerque, New Mexico, United States Curia Full time

    Senior Validation EngineerCuria is seeking a highly skilled Senior Validation Engineer to join our team in Albuquerque, NM. As a Senior Validation Engineer, you will play a critical role in ensuring the quality and integrity of our pharmaceutical products.Key Responsibilities:Develop and execute validation protocols for processes, equipment, utilities, and...

  • Systems Engineer

    1 week ago

    Albuquerque, New Mexico, United States BAE Systems USA Full time

    Job DescriptionBAE Systems USA is seeking an experienced Systems Engineer to support the engineering, development, integration, and sustainment of numerous state-of-the-art satellite ground systems in Albuquerque, NM.In this role, the Systems Engineer will support the Space Systems Center Innovation and Prototyping Directorate to develop, deploy, modernize,...

  • Lead Software Engineer

    1 week ago

    Albuquerque, New Mexico, United States Infinity Systems Engineering Full time

    Job Title: Lead Software EngineerJob Summary:Infinity Systems Engineering is seeking a highly skilled Lead Software Engineer to lead the execution of software engineering efforts for the Space Systems and Hardware Integration for Novel Space Experiments (SSHINE) program in Albuquerque, New Mexico. The successful candidate will be responsible for ensuring...

  • Senior Principal Validation Engineer

    4 weeks ago

    Albuquerque, New Mexico, United States curiate Full time

    Senior Principal Validation EngineerCuria is seeking a highly skilled Senior Principal Validation Engineer to join our team in Albuquerque, NM. As a key member of our validation team, you will be responsible for overseeing validation activities, managing projects, and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and execute...

  • Lead Software Engineer

    7 days ago

    Albuquerque, New Mexico, United States INFINITY SYSTEMS ENGINEERING LLC Full time

    Job OverviewInfinity Systems Engineering LLC is seeking a highly skilled Lead Software Engineer to lead the execution of software engineering efforts for the Space Systems and Hardware Integration for Novel Space Experiments (SSHINE) program in Albuquerque, New Mexico. The successful candidate will be responsible for ensuring customer technical success,...

  • Satellite Systems Operator Engineer

    1 week ago

    Albuquerque, New Mexico, United States BAE Systems Full time

    Job SummaryBAE Systems is seeking a highly skilled Satellite Systems Operator Engineer to join our team. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will be responsible for conducting mission/program specific real-time spacecraft/satellite flight operations during pre-launch readiness, operational and...

  • Senior Systems Engineering Lead

    4 days ago

    Albuquerque, New Mexico, United States LinQuest Full time

    LinQuest Systems Engineering Lead OpportunityLinQuest is seeking a highly skilled Senior Systems Engineering Lead to support the Air Force Nuclear Weapons Center Air Delivered Capabilities Directorate in Albuquerque, NM.The successful candidate will have demonstrated expertise in systems engineering concepts and processes, including MATE philosophies and...

  • Senior Validation Specialist

    1 month ago

    Albuquerque, New Mexico, United States Barrington James Full time

    Senior Validation EngineerBarrington James is seeking a highly skilled Senior Validation Engineer to join our team in New Mexico. As a key member of our organization, you will be responsible for developing and executing validation plans for equipment, processes, and systems to ensure compliance with regulatory standards.Key Responsibilities:Develop and...

  • Senior Systems Engineering Lead

    4 days ago

    Albuquerque, New Mexico, United States Leidos Full time

    Job Summary:We are seeking a highly skilled Lead Systems Engineer to join our team at Leidos. As a key member of our research and development team, you will be responsible for guiding the incorporation of directed energy technologies into fully capable weapon systems for the United States Air Force and other customers.Key Responsibilities:Collaborate with a...

  • Satellite Ground Systems Engineer

    4 days ago

    Albuquerque, New Mexico, United States BAE Systems USA Full time

    Job DescriptionBAE Systems USA is seeking an experienced Systems Engineer to support the engineering, development, integration, and sustainment of numerous state-of-the-art satellite ground systems in Albuquerque, NM. In this role, the Systems Engineer will support the Space Systems Center Innovation and Prototyping Directorate to develop, deploy, modernize,...

  • Senior Principal Validation Engineer

    3 weeks ago

    Albuquerque, New Mexico, United States curiate Full time

    Job Title: Senior Principal Validation EngineerCuria is seeking a highly skilled Senior Principal Validation Engineer to join our team. As a key member of our validation team, you will be responsible for overseeing validation activities, ensuring compliance with regulatory requirements, and providing technical expertise to support the development and...

  • Senior Principal Validation Engineer

    4 days ago

    Albuquerque, New Mexico, United States curiate Full time

    Job Title: Senior Principal Validation EngineerJob Summary:The Senior Principal Validation Engineer is responsible for overseeing the validation program at our Albuquerque site. This includes supervising validation contractors, reviewing project proposals, interviewing, completing bid analysis, and selecting contractors.Key Responsibilities:Manage projects...

  • Radio Frequency Systems Engineer

    4 weeks ago

    Albuquerque, New Mexico, United States Apex Systems Full time

    Job Title: RF/SATCOM EngineerApex Systems is seeking a highly skilled RF/SATCOM Engineer to join our team in Albuquerque, NM. This is a 6-month contract to permanent hire position supporting one of our largest government clients.Job Summary:We are looking for an experienced RF/SATCOM Engineer to design, develop, and implement new communication system...

  • Systems Engineer

    1 month ago

    Albuquerque, New Mexico, United States TMC Technologies Full time

    Job DescriptionTMC Technologies is seeking a highly skilled Systems Engineer to support the Space Systems Command. The ideal candidate will have experience with model-based engineering and be able to translate customer needs into technical requirements and specifications.Key ResponsibilitiesDesign, develop, and support model-based systems to support a...

  • Space Systems Lead Electrical Engineer

    3 weeks ago

    Albuquerque, New Mexico, United States Boston Full time

    About the RoleWe are seeking a highly skilled Space Systems Lead Electrical Engineer to join our team in Albuquerque, NM.Key Responsibilities:Lead a team of electrical engineers in the design and development of space systems.Collaborate with cross-functional teams to ensure successful project execution.Develop and maintain technical documentation and...

  • Space Systems Lead Electrical Engineer

    1 month ago

    Albuquerque, New Mexico, United States Catapult Solutions Group Full time

    Job Title: Space Systems Lead Electrical EngineerWe are seeking an exceptional Space Systems Lead Electrical Engineer to provide technical leadership in the electrical design of high-reliability, radiation-hardened space systems.About the RoleThis is a unique opportunity to be involved in every aspect of electrical design across various programs, supporting...

  • Senior Systems Engineer

    4 days ago

    Albuquerque, New Mexico, United States LinQuest Full time

    LinQuest is seeking a Senior Systems Engineer to lead technical efforts in Albuquerque, NM.The ideal candidate will have demonstrated expertise in systems engineering concepts and processes, including MATE philosophies and MBSE methodologies.Responsibilities:Support the Program Manager in translating strategic direction into a feasible technical path to...

  • Senior Systems Engineer

    1 week ago

    Albuquerque, New Mexico, United States ASG Full time

    Abacus Solutions Group:We're built on our shared core values: We are difference-makers, passionate about serving, we work hard with integrity and do the right thing. At ASG, we're committed to making a positive impact in the lives of our customers and colleagues. We believe in the importance of integrity, hard work, and serving others. If you share these...

  • Lead Electrical Engineer

    2 weeks ago

    Albuquerque, New Mexico, United States Sandia National Laboratories Full time

    About Sandia National LaboratoriesSandia National Laboratories is a premier science and engineering lab for national security and technology innovation, with teams of specialists focused on cutting-edge work in a broad array of areas.Why We Love Our JobsChallenging work with amazing impact that contributes to security, peace, and freedom...

  • Environmental Systems Engineer

    4 weeks ago

    Albuquerque, New Mexico, United States CDM Smith Full time

    Job Title:Environmental Engineer - Project Technical LeaderJob Summary:We are seeking an experienced Environmental Engineer to lead our project teams in the design and implementation of water and wastewater treatment facilities, water and sewer systems, pipelines, and pump stations. The successful candidate will have a strong background in environmental...

Lead Computer Systems Validation Engineer

2 months ago

Albuquerque, New Mexico, United States Curia, Inc. Full time
Position OverviewLead Computer Systems Validation Engineer

Curia, Inc. is a prominent provider of contract research and manufacturing solutions tailored for the pharmaceutical and biotechnology sectors.

The Lead Computer Systems Validation Engineer plays a vital role within the Curia Quality team. This position is tasked with enhancing Quality Management Systems and overseeing Computer System Validation initiatives. The incumbent will offer expert guidance on diverse global and site-specific CSV projects, ensuring that quality teams are equipped with the essential tools to generate quality metrics, measurements, and reports for internal evaluations and inspections.

We are proud to offer:
  • Comprehensive benefits package (available from the first day of employment)
  • Paid training, vacation, and holidays (vacation accrual starts on the first day of employment)
  • Opportunities for career progression
  • Tuition reimbursement
  • 401k retirement plan
  • Access to a learning platform
  • And additional perks
Supervisory Duties:

This position does not include supervisory responsibilities but may involve mentoring and advising team members.

Key Responsibilities:
  • Ensure that routine tasks related to the validation of electronic systems and applications supporting drug product manufacturing are documented in compliance with company protocols and health authority regulations.
  • Generate and execute validation documentation to maintain the systems/software in the most current validated state according to regulatory standards.
  • Assist cross-functional teams in identifying necessary validation deliverables for new systems/software/equipment or modifications to existing validated systems/software/equipment.
  • Conduct system/equipment impact assessments and evaluations of electronic records and signatures.
  • Perform gap analyses on vendor-executed protocols to ensure adherence to current regulations.
  • Collaborate across various functional areas to enhance and maintain computer system validation processes, ensuring robust, efficient, and compliant practices.
  • Provide support during the generation and review of specification documents (URS, FS, DDS, or CS).
  • Ensure all required Software/System Development Lifecycle Documents are prepared for regulatory and client audits, participating as necessary in site audits.
  • Develop and execute CSV change records, CAPAs, and Quality events for CSV projects.
  • Act as an investigator for any CSV deviations.
  • Support site CSV actions resulting from client or regulatory audits.
  • Serve as a subject matter expert during site audits and inspections.
  • Offer guidance on quality issues impacting data integrity or system validation.
  • Maintain an accurate inventory of all applications, hardware, and computer systems within the organization.
  • Ensure all computer systems are equipped with up-to-date antivirus and backup software.
  • Update outdated operating systems on computer systems.
  • Investigate backup failures and conduct necessary investigations.
  • Conduct periodic reviews and provide routine project status updates.
  • Maintain regular updates on software and hardware inventories.
  • Provide updates on SOPs and templates, as well as CAPA, QE, and CR updates to the compliance team.
  • Document routine audit observations and remediation efforts.
  • Ability to work at elevated heights.
  • Read and interpret SOPs to ensure compliance.
  • Maintain current training records.
  • Perform other duties as assigned.
Qualifications:
  • Provide mentorship and guidance to team members.
  • Foster a collaborative and positive work environment.
  • Champion organizational change.
  • Promote a safe and healthy workplace by proactively identifying and addressing potential hazards, adhering to safety protocols, and participating in safety training.
  • Exhibit strong attention to detail.
  • Adapt to changing circumstances while maintaining a focus on quality and information assurance.
  • Possess solid knowledge of FDA and applicable global regulations.
  • Demonstrate a proactive approach to Computer System Validation.
  • Exhibit excellent leadership and management capabilities.
  • Adjust quickly to shifting priorities and make informed decisions with limited information.
  • Highly motivated with the ability to self-initiate, prioritize, and multitask, demonstrating a positive attitude.
  • Communicate effectively and collaborate with others, leveraging diverse skills and experiences to build a strong team spirit.
  • Possess excellent verbal communication and interpersonal skills to document and convey findings, escalating critical risks to stakeholders.
Education and Experience:
  • Bachelor's degree in Engineering, Life Sciences, Information Technology, or a related field.
  • A minimum of seven (7) years of experience in a cGMP regulated industry focused on computer systems validation.
  • Experience in a cGMP quality control laboratory or sterile fill-finish operations, developing and executing SDLC documents that align with current regulatory and industry standards is preferred.
Additional Requirements:
  • Successful completion of a background check.
  • Passing a drug screening is required.
  • May require passing Occupational Health Screening.
  • May require obtaining and maintaining gowning certification.
  • May require obtaining and maintaining media qualification.
  • May require wearing a respirator.
Curia, Inc. 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.