CSV Specialist – EBR

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 to cover business needs)
Position Summary
We are seeking an experienced
Computer System Validation Specialist
to support validation and qualification activities associated with the
Syncade Manufacturing Execution System (MES)
within a regulated pharmaceutical manufacturing environment. The ideal candidate will have a strong understanding of computer system validation (CSV), GxP requirements, and manufacturing systems, with hands-on experience supporting
validation, implementation, testing, and documentation
.

Key Responsibilities

Support validation activities for the Syncade MES, including new implementations, system enhancements, upgrades, and changes.
Develop, review, and execute validation documentation in accordance with applicable procedures and regulatory requirements.
Prepare and/or execute
IQ, OQ, PQ, UAT, and regression testing
activities as applicable.
Develop and execute test scripts and document test results, deviations, and exceptions.
Support requirements gathering and development of
User Requirements Specifications (URS), Functional Specifications, and other validation deliverables
.
Ensure traceability between user requirements, functional requirements, risk assessments, and test cases.
Support
risk assessments
and validation strategy development for Syncade-related systems and processes.
Investigate and document validation discrepancies, deviations, and testing issues.
Support change control activities associated with Syncade system modifications and enhancements.
Collaborate with Manufacturing, Automation, IT, Quality, Engineering, and other cross-functional teams.
Ensure validation documentation is complete, accurate, and compliant with applicable
GxP, GMP, and data integrity
requirements.
Participate in validation planning, status meetings, execution activities, and project reviews.
Support audits and inspections by providing validation documentation and technical information as required.
Required Qualifications
Minimum of 3 years of experience
in computer system validation, MES validation, or validation of computerized systems within a regulated environment.
Hands-on experience with
MES
validation or implementation.
Experience working in a
GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing environment
.
Knowledge of computer system validation principles and applicable regulatory expectations.
Experience developing and executing validation test scripts and documenting results.
Familiarity with
risk-based validation methodologies
and change control processes.
Strong technical writing and documentation skills.
Ability to work effectively with cross-functional teams and communicate with technical and business stakeholders.

Preferred Qualifications

Experience with
Syncade system configuration, integration, or troubleshooting
.
Knowledge of MES functionality related to manufacturing, electronic batch records, materials, equipment, or production processes.
Experience with
21 CFR Part 11
, data integrity principles, and applicable GxP requirements.
Familiarity with
GAMP 5
and risk-based computerized system validation approaches.
Experience supporting system upgrades, remediation, or continuous improvement initiatives.
Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related field is preferred.