AMRI Global

CSV System Engineer II in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

The CSV Systems Engineer II is an integral part of the Curia team. The CSV Systems Engineer II will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role 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. 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties Computer Systems Validation

1. Manage multiple CSV projects at any time
2. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
3. Create the CSV deliverables for assigned CSV projects
4. Participate in SOP reviews and design process for CSV
5. Support general configurations to any CSV system based on CSV compliance standards
6. Perform CSV Risk Assessments

Quality Management

1. Own CSV change records, CAPAs and Quality events for the CSV projects
2. Act as investigator on any CSV Defects/Deviations within any project
3. Support Site CSV actions from any audits
4. Participate in all site audits /inspections as CSV subject matter expert
5. Provide guidance on quality issues that affect the integrity of the data or the system

Inventory Management

1. Gather and maintain accurate inventory of all applications, hardware, and computer systems within Curia ABQ sites (GMP and non-GMP) 

IT Compliance

1. Ensure all computer systems have up to date Antivirus software and backup software installation
2. Update computer systems that are running outdated Operating systems
3. Investigate failed backups and investigations

Periodic internal audits and inspections readiness

1. Execute periodic reviews and data collection
2. Participate in all site Audits / Inspections as CSV subject matter expert

Quality metrics, measurement, and reporting

1. Provide routine project status reports
2. Provide routine software and hardware inventory updates
3. Provide routine progress updates on SOPs and Templates
4. Provide CAPA, QE and CR updates to compliance team
5. Provide routine audit observations and remediation

Education, experience, certification and licensures Required

• Bachelor’s degree in Information Technology or related field
• Minimum 5 years’ experience in quality and computer systems validation and/or information technology

Preferred

• Experience in the pharmaceutical industry (CGMP)

Knowledge, skills and abilities

1. 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. 
2. Solid knowledge of FDA and applicable global regulations
3. Demonstrate a proactive approach to Computer System Validation
4. Possess excellent leadership and management skills
5. Ability to adjust quickly to shifting priorities, and decision-making skills with limited information
6. Highly motivated individual with the ability to self-start, prioritize, multi-task, and has a "can-do" attitude
7. Knowledge of current threats and best practices in the Information Security, Assurance, and OT security
8. Ability to communicate and work effectively with others, harness different skills and experience, and build a strong sense of team spirit
9. Excellent verbal communication, and interpersonal skills to document and communicate findings, escalate critical risks to stakeholders

Physical requirements

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.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.

All interested applicants must apply online. 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.