CSV & Change Control Specialist

Job Title : CSV & Change Control Specialist

Location : Manatí, PR

Duration : 6‑month initial term (renewable up to 3 years)

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.

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.

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

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)

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