Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative shift (flexible hours based on business needs)
Position Overview
We are seeking a qualified Computerized System Validation (CSV) Specialist to provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) within a regulated pharmaceutical manufacturing environment. The selected candidate will support the validation lifecycle of electronic batch records utilizing the Syncade Enterprise Manufacturing Execution System (EMES). Responsibilities include developing, reviewing, updating, executing, and maintaining computerized system validation documentation in accordance with applicable GMP regulations, data integrity principles, and established corporate quality standards and procedures.
Required Qualifications
- Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline preferred.
- Experience in Computerized System Validation (CSV) within pharmaceutical, biotechnology, or other regulated GMP environments.
- Knowledge of FDA cGMP regulations, Good Documentation Practices (GDP), and Data Integrity requirements.
- Experience with Manufacturing Execution Systems (MES), Electronic Batch Records (eBRs), or other GMP-regulated manufacturing applications.
- Familiarity with validation lifecycle documentation, including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
- Experience developing and executing IQ/OQ testing protocols and documenting validation results.
- Familiarity with Application Lifecycle Management (ALM) tools or electronic validation testing platforms.
- Experience working with electronic document management systems and controlled documentation workflows.
- Strong technical writing, documentation review, and organizational skills.
- Ability to coordinate activities with cross-functional technical and business teams.
- Strong communication skills and ability to provide timely project updates.
- Ability to manage multiple deliverables while meeting established project schedules and deadlines.
Preferred Qualifications
- Direct experience with Syncade Enterprise MES (EMES).
- Experience with electronic batch record implementation, configuration, and validation.
- Knowledge of pharmaceutical manufacturing processes and electronic manufacturing documentation.
- Experience with CSV risk assessments, Data Integrity Assessments, and data migration validation.
- Familiarity with ALCOA+ principles and electronic records requirements under 21 CFR Part 11.
- Experience supporting MES implementation, upgrades, enhancements, or system lifecycle projects.
Key Responsibilities
- Perform Computerized System Validation (CSV) activities associated with Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs).
- Develop, review, revise, and maintain validation lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications, Design Specifications, and Configuration Specifications.
- Develop and execute CSV risk assessments, Data Integrity Assessments, Data Mapping Assessments, and requirements traceability matrices.
- Develop, execute, and document Installation Qualification (IQ) and Operational Qualification (OQ) testing protocols.
- Execute validation test scripts and protocols using Application Lifecycle Management (ALM) systems or other designated validation platforms.
- Prepare and review validation reports, including qualification reports and Validation Plan Summary Reports.
- Support design reviews, configuration assessments, and data migration activities, as applicable.
- Develop, revise, and maintain system administration, security, and operational procedures.
- Ensure validation documentation complies with applicable cGMP requirements, Good Documentation Practices (GDP), Data Integrity principles, and established CSV procedures.
- Coordinate document reviews and approvals with cross-functional stakeholders, including IT, Manufacturing, Quality Assurance, Engineering, and system owners.
- Manage validation documentation within electronic document management systems, including document uploads, revisions, routing, and approval workflows.
- Maintain accurate validation inventories and associated system documentation.
- Coordinate multidisciplinary meetings to discuss project requirements, documentation updates, testing activities, and validation deliverables.
- Communicate project progress, potential roadblocks, outstanding requirements, and schedule risks to project leadership and CSV stakeholders.
- Support training documentation and completion of required training records.
- Address review comments, coordinate follow-up discussions, and ensure deliverables are completed within established project timelines.
- Maintain compliance with site-specific policies, procedures, training requirements, and applicable regulatory standards.
Key Deliverables
The selected resource will be responsible for developing, updating, reviewing, executing, and coordinating approval of CSV documentation and deliverables, including:
- CSV Risk Assessments and Validation Plans.
- User Requirements, Design, Functional, and Configuration Specifications.
- Data Integrity, Data Mapping, and Data Migration Assessments, as applicable.
- Design Reviews and Requirements Traceability Matrices.
- IQ/OQ Testing Protocols, Execution Records, and Qualification Reports.
- Validation Summary Reports.
- System Administration and Security SOPs.
- System Inventory and controlled documentation updates.
- Electronic document management, including document submissions, revisions, implementation, and approval workflows.
- Training documentation and completion records, as required.
- Resolution of documentation review comments and coordination of follow-up meetings to ensure timely completion of project milestones.
- Additional deliverables may be assigned based on project requirements, operational priorities, and business needs.