Job Summary/ Objective:

The CSV Specialist I will be responsible for ensuring the compliance and operation of computerized systems throughout their lifecycle. This position will be responsible for understanding and following standard operating procedures, reading and providing input on CSV lifecycle documentation, and performing protocol test scripts. This role will connect with impacted personnel throughout the validation process, document and close protocol testing, and assist with qualifying protocol activities.

Key Responsibilities:

• Read, understand and follow the standards operating procedures for the Computerized System Life Cycle documentation and process.
• Reviews, understands and makes suggestions into the Computer System Validation (CSV) lifecycle documentation.
• Read and understand protocol tests scripts and organize the preparation activities for protocol test execution.
• Communicate with personnel or areas that can be affected during validation activities by overseeing and reviewing areas, processes, and procedures related to the system to be validated.
• Perform protocol test scripts execution, documentation and closures including description, root cause and corrective actions of any deviations found during the execution.
• Reviews and executes qualification protocols and performs related tasks, including supports the protocol closure and validation summary plan and report activities.
• Acts as a team member to collaborate with colleagues on tasks assigned by SMEs, leaders or managers.
• Notify through written communications to leaders or managers of any discrepancy found between qualification protocols and specifications requirements.
• Understand base systems and information technology terminologies into GAMP principles and framework, and software application/platforms and services. 
• Provide training to end-users on system operation and standards procedures.
• Execute systems development lifecycle documentation for validation, including In-House testing, FAT, SAT, IQ, OQ and PQ. 
• Create, review and revise specifications and requirements, including system development and coding phase, functionality, safety, security, hardware, software, performance and data integrity among others
• Plan, define and create verification tests scripts strategies and documentation of qualification protocol for the validation of low and medium-risk criticality level systems.
• Collaborate with project teams to prepare and revise systems development lifecycle documentation for validation, including In-House Testing, FAT, SAT, IQ, OQ, PQ and TM of low and medium-risk criticality level systems.

Profile and Qualifications

• Bachelor’s degree in Engineering, Sciences, or related field.
• Up to 2 years’ experience is required in computer system validation, quality assurance, or regulatory compliance within a regulated industry. Relevant internships, co-op placements, or coursework can be considered.
• Exposure to and basic understanding of CSV processes and regulatory requirements.
• Familiarity with protocol test scripts and validation documentation.
• Basic knowledge of IT systems and software applications.
• Experience with standard operating procedures (SOPs) and compliance documentation.
• Fluency in English and Spanish languages (written/spoken). 
• Understanding of the Computerized System Life Cycle (CSLC) and GAMP principles.
• Knowledge of validation activities such as FAT, SAT, IQ, OQ, and PQ.

Synerlution is committed to providing equal employment opportunities for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, or veteran status. We feel that having a diverse staff increases our capacity to drive synergy through solutions for our clients. We are committed to fostering an inclusive environment in which all employees feel comfortable sharing their unique ideas and talents.