CSV & Change Control Specialist
CSV & Change Control Specialist
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Job Description
Job Title: CSV & Change Control Specialist
Location: Manat PR
Duration: 6month 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 Manat site. You will own the endtoend life cycle of electronic change controls and computerized system validation (CSV) projects ensuring compliance with BMS standards cGMP 21CFRPart11 and all applicable regulations.
Key Responsibilities
Change Control Management
Initiate & Drive electronic change controls (eCC) from creation through closureassign impact assessors coordinate endorsements and ensure system release for use.
Collaborate with crossfunctional 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 followup actions.
Cybersecurity & Data Integrity
Support cybersecurity assessments and dataintegrity/datamapping exercises.
Implement mitigation measures and ensure alignment with corporate IT security policies.
Deliverables & Milestones
Completed eCC 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
Bachelors degree in Engineering Computer Science or relatedor Masters plus 1year CSV/ChangeControl experience
5years of CSV and Change Control Management in a Pharmaceutical/Biotech environment
Handson 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
Indepth knowledge of cGMP 21CFRPart11 GAMP5 and FDA/local regulations
Bilingual English/Spanish (written and oral)
Core Competencies
Strong project planning organization and multitasking
Excellent written and verbal communication
Collaborative mindset with ability to influence across levels
Customerservice orientation and proactive problem solving
Sound judgment and commitment to quality and compliance
Required Experience:
Unclear Seniority
Employment Type
Full Time
