CSV Systems Engineer III

Curia Aalborg ApS; Albuquerque (NM); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia Albuquerque is seeking a Validation Engineer III, CSV to lead and enhance our computerized systems validation programs. You will help ensure laboratory systems are compliant, validated, and aligned with GMP operations, supporting Quality Management Systems and CSV initiatives.

Relocation reimbursement is available for qualified candidates. You will mentor teams, generate validation documents, perform risk assessments, and participate in site audits and regulatory inspections.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum of five years’ experience in computer systems validation in a cGMP setting.
• Experience with SDLC documents and regulatory expectations.

Responsibilities

• Validate electronic systems and applications per procedures and health authority regulations.
• Generate and execute validation documents to maintain current validated state.
• Collaborate across functions to define validation deliverables for new or changed systems.
• Provide guidance duringURS/FS/DDS/CS review and develop lifecycle documents.
• Support site CSV actions from audits and participate in site inspections.

Skills

CSV

GMP

FDA regs

Validation

Education

Bachelor’s degree in engineering

5+ years cGMP validation

Tools

SDLC documents

Job description

Validation Engineer III, CSV in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

This Albuquerque-based opportunity includes relocation expense reimbursement for qualified candidates and offers the chance to lead and enhance Curia's computerized systems validation (CSV) programs, ensuring laboratory systems remain compliant, validated, and aligned with GMP laboratory operations.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The Validation Engineer III, CSV (Computer System Validation) is an integral part of the Curia Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Validation Engineer III, CSV 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.

Essential Duties and Responsibilities

• The main duty of the Validation Engineer III, CSV is to 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
• Shall 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
• Ability to work at elevated heights
• 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, elevate 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

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

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. Curia is an E-Verify employer.