Job Board for Professionals in Puerto Rico

The Computer System Validation (CSV) Specialist will design, modify, develop, write, review, implement, and execute the complete GMP Computer System Validation (CSV) life cycle documents, protocols, and reports for validation and qualification work. This role responsibilities will involve validating and coordinating all validation activities (Commissioning, Qualification, and Validation) through constant communication with affected departments and personnel.  The CSV Specialist will oversee and review validation area processes and procedures, generate Standard Operating Procedures (SOP) for computerized and manufacturing systems, and produce change reports or documents for new or modified equipment.

Key Responsabilities

• Develop and standardize appropriate procedures to be used in validating computerized systems.
• Develop, review, and approve CSV policies and procedures, and champion their adoption.
• Promote excellence, lead process changes, and establish a continuous improvement framework within the CSV organization.
• Manage and control validation documentation in collaboration with QA teams.
• Implement and enforce the client's IT risk-based computerized system validation (CSV) strategy across all local and enterprise solutions (including, but not restricted to, Document Management Systems (DMS), QMS (Quality Management Systems), Building Management Systems (Client) and Clinical Data Management Systems (CDM), Process Control Systems (PCS), etc.
• Manage, coordinate, and/or perform the development of Validation, Test, and Security Access Plans, User Requirements, Functional, and Design Specifications, Supplier, Business, and Quality Risk Assessments, Development, Factory Acceptance, Site Acceptance, User Acceptance, and Installation and Qualification Testing, Traceability, and compilation of the data and results into Summary and Validation reports.
• Manage the qualification of new systems and changes to existing systems and work closely with the lead solution architects, the engagement and deployment teams, and the offshore development team(s) to ensure that CSV requirements are met.
• Responsible for the CSV elements for all systems by updating validation plans, reviewing all validation deliverables, reviewing testing coverage to ensure adequacy, performing system and supplier assessments, managing the change control process, and conducting risk analysis in order to drive and implement process improvements as required.
• Influence key stakeholders and engage senior leaders in leading CSV compliance and ensure that technology is used to support an effective and efficient approach to CSV in order to minimize business disruption.
• Schedule and lead meetings with IT, QA, and end user representatives to gain cross-functional understanding and consensus on protocol content and protocol execution.
• Lead and/or coordinate investigations into failures to meet acceptance criteria and determine and implement appropriate resolutions.
• Manage all validation aspects as part of project work, or act as lead for specific validation project resources.
• Manage formal testing of computerized systems, including identifying and implementing tools, setup of testing, documentation, approval, and delivery.
• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.

Education

• Bachelor's degree in Engineering, Sciences, or a related field.

Experience

• 4 to 8 years' experience required. 
• Demonstrable experience in successfully managing complex validation projects, ideally including experience in a successful validation of electronic Quality, Quality Management Systems (QMS), Enterprise Resource Planning Systems (ERP), etc. 
• Excellent organizational skills, with a pro-active, self-motivated approach, able to work effectively with minimum direction, exercise considerable latitude in determining assignment objectives, determine appropriate methods to apply to new assignments, and prioritize and simultaneously manage multiple projects and deadlines, always ensuring compliance to global CSV processes. 
• Relies on limited experience and judgment to plan and accomplish goals. 
• Knowledge of commonly used concepts, practices, and procedures in federal and state regulations. 
• Ability to effectively manage a wide range of complex, cross-functional area problems through the application of technical skills, ingenuity, and creativity. 
• Experience in providing guidance and working with company personnel and contractors. 
• Experience involvement in regulatory inspections and audits, able to guide as a backup contact for the CSV validation program for inspectors during inspections and audits. 
• Proficiency of computer programs: Microsoft Office (Word, Excel) 
• Fluency in English and Spanish languages (written/spoken).

Physical Demands

• Sitting: Frequently 
• Standing/ Walking: Intermittent  
• Lift/ Carry over: Not to exceed 20 lbs.
• Repetitive motions:  Typing on keyboard - Frequent
• Work Schedule: Require flexible time, including the capacity to work overtime, different schedules, and holidays or weekends as needed.
• Travel Requirements: Availability to work and travel in PR/US

Benefits

• Competitive salary
• Comprehensive benefits package
• Requires both field and office work.
• Opportunities for career advancement and professional development

Equal Opportunity Statement

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. Synerlution strictly condemns all forms of discrimination and harassment and provides a respectful, supportive, and bias-free workplace. We value all forms of diversity and are dedicated to offering equal opportunities for employees to advance and grow professionally.