CSV Systems Engineer II

CSV Systems Engineer-II
Albuquerque, NM

The CSV Systems Engineer II is an integral part of the Curia Quality 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.

Responsibilities: 

• The primary responsibilities of the CSV Engineer-II, are to ensure that routine tasks supporting the validation of electronic systems and applications supporting commercial drug product manufacturing, are documented in accordance with the relevant company procedures and health authority regulations
• Shall be able to 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
• Shall ensure that all required Software/System Development Lifecycle Documents are available for regulatory and client audits, and participate as needed in site audits.

Quality Management

• Develop and execute CSV change records (Chagne Controls), CAPAs and Quality events for CSV projects
• Act as investigator on any CSV Deviations
• Support Site CSV actions resulting from client/regualtoryaudits
• Participate as site SME in  site audits /inspections
• Provide guidance on quality issues that affect the integrity of data or  system validation

Inventory Management

• Maintain accurate inventory of all applications, hardware, and computer systems within the Curia Albuquerque site

IT Compliance (Review of systems)

• 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

Periodic internal audits and inspections readiness

• Execute periodic reviews 

Quality metrics, measurement, and reporting

• 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

Education, experience, certification and licensures required:

• Bachelor's degree in Engineer field, Science, Information Technology or related field
• Minimum 5 years' experience working in the cGMP regulated industry specific to  computer systems validation 

Preferred

• Validation experience in a cGMP quality control laboratory or sterile fill finish operations, developing and executing SDLC documents that meet current regulatory and industry expectations.

Knowledge, skills and abilities

• 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
• Knowledge of current threats and best practices in the Information Security, Assurance, and OT security
• 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

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. 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.

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