CSV Specialist: MES/eBR Validation for GMP Manufacturing

Inteldot; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking a qualified CSV Specialist to provide validation and documentation support for MES and eBRs in a regulated pharmaceutical manufacturing environment. The role focuses on validation lifecycle activities for the Syncade EMES system, ensuring compliance with GMP, GDP, and data integrity standards.

The ideal candidate will develop and execute IQ/OQ protocols, maintain validation documentation, and coordinate with IT, Manufacturing, QA, and engineering teams to meet project

Qualifications

• Bachelor’s degree in engineering, computer science, information technology, life sciences, chemistry, or related technical discipline.
• Experience in Computerized System Validation (CSV) within pharma, biotech, or other regulated GMP environments.
• Knowledge of FDA cGMP, GDP, and data integrity requirements.
• Experience with MES, eBRs, or other GMP-regulated manufacturing applications.
• Familiarity with validation lifecycle docs: URS, FS, DS, CS, RAs, and TRMs.
• Experience developing and executing IQ/OQ testing protocols and documenting results.
• Familiarity with ALM tools or electronic validation platforms.
• Experience with electronic document management systems and controlled documentation workflows.
• Strong technical writing, documentation review, and organizational skills.
• Ability to coordinate activities with cross-functional teams.
• Strong communication and timely project updates.
• Ability to manage multiple deliverables and meet schedules.

Responsibilities

• Perform CSV activities for MES and eBRs.
• Develop, review, revise, and maintain validation documents (Plans, URS, FS, DS, CS).
• Develop and execute CSV risk, Data Integrity, and mapping assessments and TRMs.
• Develop, execute IQ/OQ testing protocols.
• Execute validation tests using ALM systems or validation platforms.
• Prepare and review validation reports (qualification reports, Summary Reports).
• Support design reviews, configuration assessments, and data migration activities.
• Maintain system administration, security, and SOPs.
• Ensure CSV documents comply with cGMP, GDP, and CSV procedures.
• Coordinate document reviews with IT, Manufacturing, QA, Engineering, and system owners.
• Manage validation docs in electronic management systems and approvals workflows.
• Maintain validation inventories and documentation updates.
• Coordinate multidisciplinary meetings and track milestones.
• Communicate progress, roadblocks, and risks to leadership and stakeholders.
• Support training documentation and records.

Skills

CSV validation

GMP compliance

Regulatory documentation

Cross-functional coordination

Technical writing

IQ/OQ testing

Data integrity

ALM tools

Electronic document mgmt

Project management

Communication skills

Ability to manage multiple deliverable

Education

Bachelor’s degree in engineering, CS, IT, life sciences, chemistry, or related field

Tools

Syncade EMES

ALM tools

Electronic document management systems

Job description

Inteldot is seeking a qualified CSV Specialist to provide validation and documentation support for MES and eBRs in a regulated pharmaceutical manufacturing environment. The role focuses on validation lifecycle activities for the Syncade EMES system, ensuring compliance with GMP, GDP, and data integrity standards.

The ideal candidate will develop and execute IQ/OQ protocols, maintain validation documentation, and coordinate with IT, Manufacturing, QA, and engineering teams to meet project