CSV/CQV Validation Lead - Pharmaceutical Industry

About the Position:

Arthur Lawrence is seeking an experienced CSV/CQV Validation Lead for a long-term assignment with Ellab in San Juan, Puerto Rico.

The selected professional will lead Computer System Validation and Commissioning, Qualification, and Validation activities involving computerized systems, utilities, manufacturing/process equipment, and laboratory equipment. This person will coordinate cross-functional teams, establish validation strategies, manage project documentation, and ensure compliance with applicable FDA and GMP requirements.

Key Responsibilities

• Lead CSV and CQV activities across computerized systems, utilities, process equipment, manufacturing systems, and laboratory equipment.
• Develop and execute validation plans, project strategies, schedules, and risk assessments.
• Author, review, and approve validation lifecycle documentation, including:
• • Validation Plans and Validation Master Plans
  • User Requirements Specifications (URS)
  • Functional and Design Specifications (FS/DS)
  • Risk assessments
  • Traceability matrices
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary and Final Reports
• Ensure systems and equipment comply with FDA regulations, 21 CFR Part 11, GAMP 5, GMP/cGMP, and GxP requirements.
• Coordinate activities with Quality, IT, Engineering, Manufacturing, laboratory teams, system owners, project managers, and external vendors.
• Guide testing and release activities, including the management of deviations, discrepancies, failed test cases, CAPAs, and change controls.
• Mentor and provide technical guidance to CSV analysts and other project stakeholders.
• Track validation progress and report project status, risks, issues, and results to management.
• Manage multiple validation priorities while ensuring deliverables meet quality standards and project deadlines.
• Support regulatory inspections, quality audits, and remediation activities when required.

Required Qualifications:

• At least 15 years of relevant professional experience.
• At least two years of experience leading or managing validation projects.
• Extensive CSV and/or CQV experience within pharmaceutical, biotechnology, medical-device, or another regulated life-sciences environment.
• Strong knowledge of FDA regulations, 21 CFR Part 11, GAMP 5, GMP/cGMP, GxP, and data-integrity requirements.
• Hands-on experience developing, reviewing, and approving VMP, URS, FS, DS, risk assessments, traceability matrices, IQ/OQ/PQ protocols, and final reports.
• Experience leading cross-functional project teams and coordinating with system owners and vendors.
• Excellent written and verbal communication skills.
• Strong leadership, organization, documentation, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced, highly regulated environment.

Preferred Qualifications:

• Experience validating computerized systems, manufacturing equipment, laboratory equipment, utilities, and facilities.
• Experience with systems such as LIMS, MES, ERP, SCADA, PLC, DeltaV, TrackWise, or laboratory instruments.
• Experience supporting FDA inspections or other regulatory audits.
• Knowledge of risk-based validation, electronic records, electronic signatures, audit trails, and data integrity.
• Experience managing validation deviations, CAPAs, change controls, and periodic reviews.
• Bachelor’s degree in Engineering, Chemistry, Computer Science, Life Sciences, or a related discipline.

Why Consider This Opportunity?

• Long-term project expected to continue for more than two years.
• Leadership role supporting critical validation initiatives.
• Opportunity to work across CSV, equipment qualification, utilities, manufacturing, and laboratory environments.
• Competitive hourly compensation with flexibility for highly qualified candidates.