CSV Systems Engineer III

CSV Systems Engineer III in Albuquerque, NM

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

TheCSV Systems Engineer III 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 CSV Systems Engineer III 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.

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

• Learning platform

• And more!

Supervisory Responsibilities:

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

Essential Duties and Responsibilities:

• The main duty of the CSV Systems Engineer III 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.

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.

Physical Demands:

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.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

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 .