CSV Systems Engineer III

Essential Duties and Responsibilities

• 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 requirements.
• Assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment.
• Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments.
• Perform gap assessments on vendor executed protocols, ensuring compliance to current regulations are met and maintained.
• Collaborate across functional areas across the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.
• Provide guidance/support during specification (URS, FS, DDS or CS) document generation and review.
• 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 projects.
• Act as investigator on any CSV Deviations.
• Support Site CSV actions resulting from client/regulatory audits.
• Participate as site SME in site audits/inspections.
• Provide guidance on quality issues that affect the integrity of data or system validation.
• Maintain accurate inventory of all applications, hardware, and computer systems within the Curia Albuquerque site.
• Ensure all computer systems have up to date Antivirus software and backup software installation.
• Update computer systems that are running outdated Operating systems.
• Investigate failed backups and investigations.
• Execute periodic reviews.
• Provide routine project status reports.
• Provide routine software and hardware inventory updates.
• Provide routine progress updates on SOPs and Templates.
• Provide CAPA, QE and CR updates to compliance team.
• Provide routine audit observations and remediation.
• Read/interpret SOPs to ensure compliance.
• Maintain up to date trainings.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in Engineering, Life Science, Information Technology or related field.
• Minimum of five (5) years’ relevant experience working in a cGMP regulated industry specific to computer systems validation.
• Validation 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.

Supervisory Responsibilities

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Other Skills and Abilities

• Provides guidance and mentorship to team members.
• Fosters a collaborative and positive work environment.
• Champions change.
• Promotes 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 detail.
• Ability to adapt to changing circumstances and manage activities to meet the needs of the business while maintaining a focus on quality and information assurance.
• Solid knowledge of FDA and applicable global regulations.
• Demonstrate a proactive approach to Computer System Validation.
• Possess excellent leadership and management skills.
• Ability to adjust quickly to shifting priorities, and decision-making skills with limited information.
• Highly motivated individual with the ability to self-start, prioritize, multi-task, and has a "can-do" attitude.
• Ability to communicate and work effectively with others, harness different skills and experience, and build a strong sense of team spirit.
• Excellent verbal communication, and interpersonal skills to document and communicate findings, escalate critical risks to stakeholders.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• May be required to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.