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Lead Computer System Validation Engineer

2 months ago

Albuquerque, New Mexico, United States curiate Full time

Position: Senior Computer System Validation Engineer

Location: Albuquerque, NM

Company Overview: Curia is a leading provider of global contract research and manufacturing services tailored for the pharmaceutical and biotechnology sectors.

Role Overview: The Senior Computer System Validation Engineer plays a crucial role within the Curia Quality team. This position is tasked with supporting Quality Management Systems and Computer System Validation initiatives. The engineer will offer expertise and guidance on various global and site-specific CSV projects, ensuring that quality teams are equipped with the necessary tools to generate quality metrics, measurements, and reports for internal audits and inspections.

Key Responsibilities:

  • Ensure that routine tasks related to the validation of electronic systems and applications in commercial drug product manufacturing are documented according to company procedures and health authority regulations.
  • Generate and execute validation documents to maintain the system(s)/software in a validated state as per regulatory requirements.
  • 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 electronic record assessments.
  • Perform gap assessments on vendor-executed protocols to ensure compliance with current regulations.
  • Collaborate across functional areas to enhance computer system validation processes, ensuring they are robust, efficient, and compliant.
  • Provide support during the generation and review of specification documents (URS, FS, DDS, or CS).
  • Ensure availability of all required Software/System Development Lifecycle Documents for regulatory and client audits and participate as needed 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.
  • Participate as a subject matter expert in site audits and inspections.
  • Maintain an accurate inventory of all applications, hardware, and computer systems at the site.
  • Ensure all computer systems are equipped with up-to-date antivirus and backup software.
  • Investigate failed backups and perform periodic reviews.
  • Provide routine project status reports and updates on software and hardware inventory.
  • Maintain up-to-date training records and ensure compliance with SOPs.

Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, Information Technology, or a related field.
  • A minimum of seven years of experience in a cGMP regulated industry, specifically in computer systems validation.
  • Experience in a cGMP quality control laboratory or sterile fill finish operations is preferred.

Other Requirements:

  • Must pass a background check and drug screening.
  • May require passing Occupational Health Screening and obtaining gowning certification.
  • Must be able to adapt to changing circumstances and manage activities to meet business needs while focusing on quality.

Curia is an Equal Opportunity Employer, and 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.