Senior QA Validation Specialist - CSV Systems Engineer

Senior QA Validation Specialist - CSV Systems Engineer

Summary:

The Senior QA Validation Specialist - CSV Systems Engineer 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 Senior CSV Systems Engineer 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 
• Paid training, vacation and holidays 
• Career advancement opportunities 
• Education reimbursement
• 401k program
• And more! 

 Essential Duties and Responsibilities: 

The main duty of the Senior CSV Engineer is to ensure that routine tasks related to validating electronic systems and applications used in commercial product manufacturing are documented in compliance with company procedures and health authority regulations. 

• Will act as Site System Admin, especially site Quality Control and Manufacturing computerized systems
• 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 New York, Inc.
• 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 by QA manager and/or QA director 

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 regula