Job Title: CSV & Change Control Specialist
Location: Manatí, PR
Duration: 6‑month initial term (renewable up to 3 years)

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Position Overview

WeilGroup is seeking two seasoned CSV & Change Control Specialists to support the Business Insights & Technology (BI&T) department at our Manatí site. You will own the end‑to‑end life cycle of electronic change controls and computerized system validation (CSV) projects, ensuring compliance with BMS standards, cGMP, 21 CFR Part 11, and all applicable regulations.

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Key Responsibilities

Change Control Management

• Initiate & Drive electronic change controls (e‑CC) from creation through closure—assign impact assessors, coordinate endorsements, and ensure system release for use.

• Collaborate with cross‑functional stakeholders (Quality, IT, Engineering) to review and update all related documentation.

• Communicate status, roadblocks, and requirements to BI&T leadership on a regular cadence.

Computerized System Validation (CSV)

• Plan & Execute risk assessments (CSV & site) and develop, approve, and execute CSV deliverables:

  • Validation Plans & Summary Reports

  • URS, Design/Functional Specifications, Configuration Specifications

  • Traceability Matrices (initial and final)

  • Factory/Site Acceptance Tests (FAT/SAT) and Installation/Operational Qualification (IQ/OQ) protocols & reports

• Maintain all CSV artifacts in the BMS Document Management System; drive review and approval workflows.

Documentation & Training

• Develop/Revise SOPs for administration, security, backup, disaster recovery, and inventory control.

• Coordinate training sessions and capture completion records, forms, and follow‑up actions.

Cybersecurity & Data Integrity

• Support cybersecurity assessments and data‑integrity/data‑mapping exercises.

• Implement mitigation measures and ensure alignment with corporate IT security policies.

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Deliverables & Milestones

• Completed e‑CC records (initiation through closure)

• Approved CSV risk assessments and validation plans

• Executed FAT/SAT, IQ/OQ/PQ protocols with supporting reports

• Updated URS, specifications, traceability matrices, and SOPs

• Dashboards or summary reports tracking project progress and compliance status

• Training completion documentation and audit readiness evidence

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Minimum Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related—or Master’s plus 1 year CSV/Change‑Control experience

• ≥ 5 years of CSV and Change Control Management in a Pharmaceutical/Biotech environment

• Hands‑on experience developing and executing CSV deliverables (risk assessments, FAT/SAT, IQ/OQ/PQ)

• Proficient with Microsoft Office (Word, Excel, Project), CMMS, and Document Management Systems

• Familiarity with PI System, ColdStream, and TempTale preferred

• In‑depth knowledge of cGMP, 21 CFR Part 11, GAMP 5, and FDA/local regulations

• Bilingual English/Spanish (written and oral)

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Core Competencies

• Strong project planning, organization, and multi‑tasking

• Excellent written and verbal communication

• Collaborative mindset with ability to influence across levels

• Customer‑service orientation and proactive problem solving

• Sound judgment and commitment to quality and compliance