CSV Systems Engineer III

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.

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, 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

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

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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. Curia is an E-Verify employer.